AzTrials
AzTrials

Influenza, HumanNCT03278067

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

An observational study of Influenza, Human, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination. Read more about this study

Who is it for?
Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
Enhanced vaccine safety surveillance
Type of treatment
Vaccines
How many people
23,939 participants
Where
1 siteUnited Kingdom
Study dates
12 Sep 2017to 30 Nov 2017
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Registered patients in up to 10 general practices in UK immunized against seasonal influenza at the beginning of 2017/18 season.

Who may be able to join

  • All individuals who receive influenza vaccination among the 10 participating GP practices between 1 September and 30 November 2017 are eligible for inclusion in the analysis.

Who cannot join

  • Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    Surrey, GU2 7XH

Other trials in United Kingdom

About this study

Official title: Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18

This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.

Read the detailed description

This is the third pilot study following, EPI-FLU-045 VS UK [NCT02567721] and EPI-FLU-046 VS UK [NCT02893878] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.

Being tested
Enhanced vaccine safety surveillance
Keywords
England, Adverse Event of Interest, Seasonal influenza vaccines, Pilot study, Prospective passive enhanced safety surveillance
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced vaccine safety surveillanceOther

    Also called Data collection

    Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.

Study groups in NCT03278067
Study groupRoleWhat they receive
Vaccinated_Fluarix Tetra GroupVolunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017.
Receives: Other: Enhanced vaccine safety surveillance
Vaccinated_Non GSK GroupVolunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017.
Receives: Other: Enhanced vaccine safety surveillance
Vaccinated_Unknown GroupVolunteered subjects who received influenza vaccination (GSK or non-GSK not known) in 10 volunteer GP practices between 01 September and 30 November 2017.
Receives: Other: Enhanced vaccine safety surveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group

    The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  2. Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group

    The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  3. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

    Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  4. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

    Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  5. Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group

    Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  6. Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group

    Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  7. Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group

    General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  8. Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group

    General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  9. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group

    Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  10. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group

    Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  11. Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group

    Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  12. Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group

    Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea and, vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  13. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group

    Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  14. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group

    Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  15. Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group

    The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  16. Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group

    The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  17. Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group

    Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  18. Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group

    Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  19. Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group

    Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  20. Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group

    Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  21. Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group

    The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card;
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine.

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  22. Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group

    The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card;
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine.

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017.

    Measured: Within 7 days post vaccination

  23. Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  24. Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  25. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  26. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  27. Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  28. Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  29. Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  30. Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  31. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  32. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  33. Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  34. Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  35. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial oedema and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  36. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  37. Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  38. Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  39. Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  40. Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  41. Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  42. Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group

    AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  43. Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group

    SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  44. Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group

    SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  45. Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status

    The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  46. Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  47. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  48. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  49. Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  50. Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  51. Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  52. Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  53. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  54. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  55. Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  56. Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  57. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  58. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  59. Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  60. Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  61. Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  62. Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  63. Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  64. Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  65. Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  66. Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

    The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

Secondary outcomes (66)

  1. Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from General Practitioners (GPs). The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  2. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  3. Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  4. Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  5. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  6. Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  7. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  8. Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  9. Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  10. Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  11. Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group

    SAEs reported here are derived from 2 sources of data - ADR cards and SAE routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  12. Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  13. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group

    "subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  14. Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  15. Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  16. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  17. Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card
    • The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  18. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  19. Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  20. Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  21. Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  22. Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group

    SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  23. Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  24. Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  25. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years, and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine

    Vaccination of subjects happened between weeks 35 and 48 of the year 2017

    Measured: Within 7 days post vaccination

  26. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of the year 2017

    Measured: Within 7 days post vaccination

  27. Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  28. Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  29. Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  30. Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  31. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator = the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator = the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine

    Vaccination happened between weeks 35 and 48, of 2017

    Measured: Within 7 days post vaccination

  32. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + ADR) within 7 days following vaccination with seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48, 2017

    Measured: Within 7 days post vaccination

  33. Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  34. Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The cumulative incidence rates of AEIs expressed as a cumulative percentage of subjects, were estimated as follows:

    The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system); The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine.

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  35. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of the year 2017

    Measured: Within 7 days post vaccination

  36. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of 2017

    Measured: Within 7 days post vaccination

  37. Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  38. Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  39. Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  40. Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  41. Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of 2017

    Measured: Within 7 days post vaccination

  42. Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group

    AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between weeks 35 and 48 of 2017

    Measured: Within 7 days post vaccination

  43. Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group

    "SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017"

    Measured: Within 7 days post vaccination

  44. Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group

    SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  45. Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  46. Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  47. Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  48. Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  49. Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  50. Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  51. Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  52. Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  53. Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  54. Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  55. Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  56. Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  57. Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  58. Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  59. Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  60. Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  61. Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  62. Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  63. Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  64. Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  65. Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)within 7 days following vaccination with the seasonal influenza vaccine

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

  66. Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

    SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:

    • The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)
    • The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)

    Vaccination of the subjects happened between week 35 and week 48 of the year 2017

    Measured: Within 7 days post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2017
  2. Study start12 Sep 2017
  3. Primary completion30 Nov 2017
  4. Study completion30 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
23,939 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03278067
Sponsor's protocol ID
207781
Status last verified
Jan 2020
First submitted
8 Sep 2017
Last updated
13 Jan 2020
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • de Lusignan S, Damaso S, Ferreira F, Byford R, McGee C, Pathirannehelage S, Shende V, Yonova I, Schmidt A, Schuind A, Dos Santos G. Brand-specific enhanced safety surveillance of GSK's Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season. Hum Vaccin Immunother. 2020 Aug 2;16(8):1762-1771. doi: 10.1080/21645515.2019.1705112. Epub 2020 Mar 2.

    PubMed 32118513

Questions about this trial

What is this clinical trial studying?

An observational study of Influenza, Human, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group (time frame: Within 7 days post vaccination). The study lists 66 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03278067, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT03278067 | AzTrials