InfluenzaNCT02567721
Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
An observational study of Influenza, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Vaccine safety surveillance
- Type of treatment
- Vaccines
- How many people
- 11,530 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
Who may be able to join
- All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.
- Pregnant women are also included in this study.
Who cannot join
- Only 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.
About this study
Official title: European Medicines Agency (EMA) Post-authorisation Safety Study of Influenza Vaccine
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.
Read the detailed description
Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine. This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.
- Conditions
- Influenza
- Being tested
- Vaccine safety surveillance
- Keywords
- Post-authorisation safety study (PASS), Adverse Drug Reaction Reporting Systems, Post marketing product surveillance, European Medicines Agency (EMA), Influenza Vaccine, Computerized Medical Record System, United Kingdom, Primary Health Care
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine safety surveillanceOther
Also called Data collection
Extraction of routinely collected primary care data from nine GP practices and an active surveillance approach in 3 of the 9 GP practices, by using an existing card-based ADR reporting system (MHRA Yellow Card), to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Subjects who will receive influenza vaccination between 1 September 2015 and 30 November 2015 in the 9 GP practices from who clinical data routinely collected as part of clinical consultations in primary care will be extracted. Receives: Other: Vaccine safety surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient counts of the total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Proportions of total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Number of patient counts of the total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Proportions of total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Number of patient counts of the vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Proportions of vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Number of patient counts of the vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Proportions of vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Secondary outcomes (9)
Completeness of vaccination data in the computerized medical record system.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of AEI reporting in the computerized medical record system.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of vaccination data in the computerized medical record system.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of AEI reporting in the computerized medical record system.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of vaccination data in the card-based adverse event reporting system.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of AEI reporting in the card-based adverse event reporting system.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of vaccination data in the card-based adverse event reporting system.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of AEI reporting in the card-based adverse event reporting system.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Incidence rates for the 5 most frequently reported AEs reported alongside those available in the literature from a similar population (vaccinated or general population if vaccinated not available) within the same risk period and stratified by age.
Measured: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 11,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Surrey
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567721
- Sponsor's protocol ID
- 202055
- Status last verified
- Feb 2016
- First submitted
- 18 Sep 2015
- Last updated
- 12 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Medicines Agency (EMA) Post-authorisation Safety Study of Influenza Vaccine
- ClinicalTrials.gov ID
- NCT02567721
- Acronym / sponsor ID
- 202055
- Conditions
- Influenza
- Keywords
- Post-authorisation safety study (PASS), Adverse Drug Reaction Reporting Systems, Post marketing product surveillance, European Medicines Agency (EMA), Influenza Vaccine, Computerized Medical Record System, United Kingdom, Primary Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,530 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- University of Surrey
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.
Detailed description
Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine. This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Vaccine safety surveillanceSubjects who will receive influenza vaccination between 1 September 2015 and 30 November 2015 in the 9 GP practices from who clinical data routinely collected as part of clinical consultations in primary care will be extracted. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
Key inclusion criteria (2 listed)
- All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.
- Pregnant women are also included in this study.
Key exclusion criteria (1 listed)
- Only registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine safety surveillanceAlso: Data collectionExtraction of routinely collected primary care data from nine GP practices and an active surveillance approach in 3 of the 9 GP practices, by using an existing card-based ADR reporting system (MHRA Yellow Card), to estimate proportions of AEIs among seasonal influenza-vaccinated individuals. | Other | Study Cohort |
Primary outcome
Number of patient counts of the total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Proportions of total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Number of patient counts of the total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Proportions of total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Number of patient counts of the vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
Proportions of vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
Number of patient counts of the vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
Proportions of vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
9 secondary outcomes
Completeness of vaccination data in the computerized medical record system.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of AEI reporting in the computerized medical record system.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of vaccination data in the computerized medical record system.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of AEI reporting in the computerized medical record system.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of vaccination data in the card-based adverse event reporting system.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of AEI reporting in the card-based adverse event reporting system.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of vaccination data in the card-based adverse event reporting system.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of AEI reporting in the card-based adverse event reporting system.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Incidence rates for the 5 most frequently reported AEs reported alongside those available in the literature from a similar population (vaccinated or general population if vaccinated not available) within the same risk period and stratified by age.
Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, 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 2 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 12 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patient counts of the total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable) (time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2016.