InfluenzaINOCULATENCT06077045
Uptake of the Childhood Live Attenuated Influenza Vaccine (LAIV) and Influenza-related Healthcare Resource Use in England During the 2012 to 2022 Flu Seasons; a Retrospective, Observational Study in the CPRD and HES Databases
An observational study of Influenza, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
In 2013, the NHS started a vaccination program in some regions of England to provide free flu vaccines to children aged 2 years or older, and younger than 16 years. The program has since been rolled out across England. Most children are given a vaccine that is sprayed into their nose. Read more about this study
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study will include all research eligible children born between the 1st January 1994 and 31st August 2020 (latest date at which a child can be aged 2 years or above in the study period and have at least six months follow up in the most recent data), with 6 months of medical history available in CPRD before their the 1st September in the first year they are aged 2 years or above. The childhood influenza programme has been conducted on a rolling basis since 2013. Classification of each child as eligible for the vaccine will therefore vary year on year depending on their age, GP practice location and presence of high-risk conditions.
Who may be able to join
- Aged ≥6 months and <2 years on the 1st September
- Have a high-risk condition as listed in the Green Book.
Who cannot join
- Were deceased or had migrated out of their practice prior to the 1st September in the current influenza season.
- Were recorded has receiving both QIV and LAIV in the current influenza season.
Trial locations and contacts
1 site in 1 country.
About this study
In 2013, the NHS started a vaccination program in some regions of England to provide free flu vaccines to children aged 2 years or older, and younger than 16 years. The program has since been rolled out across England. Most children are given a vaccine that is sprayed into their nose. In clinical trials, this vaccine has been shown to protect children from experiencing severe flu symptoms. It is important to describe how it is used, and what happens to children who receive it in the wider community. This evidence will help the NHS to check that the vaccine roll out runs as planned and produces the intended benefits.
This study aims to: (1) describe how many children each year receive flu vaccines, and describe the characteristics of children who are and aren't vaccinated for influenza; (2) test how often children receiving the vaccine see their GP or a hospital doctor for symptoms related to flu, compared to those who don't; and (3) to test what groups of children are more or less likely to receive a flu vaccine. To answer these objectives, the study will use the Clinical Practice Research Datalink, linked to Hospital Episode Statistics and the Office for National Statistics database.
Read the detailed description
A Live Attenuated Influenza Vaccination (LAIV) has been offered to children through a rolling national program in England since 2013. Previous observational studies identified trends in LAIV uptake that varied with demographic and clinical profiles.
The general aim of this study is to provide up-to-date epidemiological evidence on the uptake of the influenza vaccines, and influenza related HCRU outcomes in children in England. The specific study objectives are given below.
Primary objective:
- To evaluate the uptake of influenza vaccines in children aged ≥2 and <18 years in England between 2012 and 2020 for LAIV, QIV, and influenza vaccinations where the product is not specified
Secondary objectives:
2.1 To describe usage patterns of LAIV in England between 2012 and 2020. 2.2 To describe HCRU associated with laboratory confirmed influenza and/or influenza-like-illness (ILI) in England between 2012 and 2020 and assess the relative impact of LAIV on HCRU use of LAIV vs no vaccination 2.3 To describe demographics and clinical characteristics of individuals vaccinated with LAIV or not vaccinated against flu by any vaccine in each flu season between 2012 and 2020 2.4 To estimate a DAG aligned model for LAIV uptake in England based on demographic and clinical factors for each flu season and across multiple seasons between 2012 and 2020
The study will include all research eligible aged between ≥2 and <18 years in the study period, with 6 months of history in CPRD before their first influenza vaccination. It will use the Clinical Practice Research Datalink data (vaccinations, diagnoses, characteristics) linked to Hospital Episode Statistics (HCRU). Logistic regression analyses will be used to test for factors associated with vaccine uptake, and outcomes between vaccinated and unvaccinated children. The study will provide up-to-date epidemiological evidence on the uptake of LAIV and its impact on HCRU related to ILI in children in England. This may be used by the NHS for planning and evaluation of the childhood influenza vaccination program.
- Conditions
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LAIV Vaccinated cohort | All individuals receiving LAIV between 2 and <18 years within a given flu season between 2012 and 2020. | |
| Unvaccinated cohort | All individuals between 2 and <18 years with no record of influenza vaccinations in a given flu season |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of influenza vaccination
Proportion of eligible individuals receiving a flu vaccine (LAIV, QIV, other)
Measured: Per flu season (defined as 1st September in a given year to the 30th April the following year )
Secondary outcomes (8)
GP consultations for ILI (influenza-like illness)
Rate of GP consultations for ILI per 100,000 person years.
Measured: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Laboratory confirmed influenza
Rate of Laboratory confirmed influenza for ILI per 100,000 person years.
Measured: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Admitted Patient Care (APC) episodes associated with ILI
Rate of Admitted Patient Care (APC) for ILI per 100,000 person years.
Measured: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Accident and Emergency (A&E) attendances associated with ILI
Rate of A\&E for ILI per 100,000 person years.
Measured: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Outpatient attendances associated with ILI
Rate of Outpatient attendances associated with ILI per 100,000 person years.
Measured: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Length of stay in APC for influenza and ILI
Average length of stay in hospital for influenza and ILI
Measured: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Number of antibiotic prescriptions
Counts of antibiotic prescriptions
Measured: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Number of antiviral prescriptions
Counts of antiviral prescriptions
Measured: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start18 Jan 2023
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
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 AstraZenecaThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,775,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077045
- Sponsor's protocol ID
- D2560R00011
- Acronym
- INOCULATE
- Status last verified
- Apr 2025
- First submitted
- 12 Jul 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uptake of the Childhood Live Attenuated Influenza Vaccine (LAIV) and Influenza-related Healthcare Resource Use in England During the 2012 to 2022 Flu Seasons; a Retrospective, Observational Study in the CPRD and HES Databases
- ClinicalTrials.gov ID
- NCT06077045
- Acronym / sponsor ID
- INOCULATE / D2560R00011
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,775,880 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 11 Oct 2023 (actual)
- 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.
In 2013, the NHS started a vaccination program in some regions of England to provide free flu vaccines to children aged 2 years or older, and younger than 16 years. The program has since been rolled out across England. Most children are given a vaccine that is sprayed into their nose. In clinical trials, this vaccine has been shown to protect children from experiencing severe flu symptoms. It is important to describe how it is used, and what happens to children who receive it in the wider community. This evidence will help the NHS to check that the vaccine roll out runs as planned and produces the intended benefits.
This study aims to: (1) describe how many children each year receive flu vaccines, and describe the characteristics of children who are and aren't vaccinated for influenza; (2) test how often children receiving the vaccine see their GP or a hospital doctor for symptoms related to flu, compared to those who don't; and (3) to test what groups of children are more or less likely to receive a flu vaccine. To answer these objectives, the study will use the Clinical Practice Research Datalink, linked to Hospital Episode Statistics and the Office for National Statistics database.
Detailed description
A Live Attenuated Influenza Vaccination (LAIV) has been offered to children through a rolling national program in England since 2013. Previous observational studies identified trends in LAIV uptake that varied with demographic and clinical profiles.
The general aim of this study is to provide up-to-date epidemiological evidence on the uptake of the influenza vaccines, and influenza related HCRU outcomes in children in England. The specific study objectives are given below.
Primary objective:
- To evaluate the uptake of influenza vaccines in children aged ≥2 and <18 years in England between 2012 and 2020 for LAIV, QIV, and influenza vaccinations where the product is not specified
Secondary objectives:
2.1 To describe usage patterns of LAIV in England between 2012 and 2020. 2.2 To describe HCRU associated with laboratory confirmed influenza and/or influenza-like-illness (ILI) in England between 2012 and 2020 and assess the relative impact of LAIV on HCRU use of LAIV vs no vaccination 2.3 To describe demographics and clinical characteristics of individuals vaccinated with LAIV or not vaccinated against flu by any vaccine in each flu season between 2012 and 2020 2.4 To estimate a DAG aligned model for LAIV uptake in England based on demographic and clinical factors for each flu season and across multiple seasons between 2012 and 2020
The study will include all research eligible aged between ≥2 and <18 years in the study period, with 6 months of history in CPRD before their first influenza vaccination. It will use the Clinical Practice Research Datalink data (vaccinations, diagnoses, characteristics) linked to Hospital Episode Statistics (HCRU). Logistic regression analyses will be used to test for factors associated with vaccine uptake, and outcomes between vaccinated and unvaccinated children. The study will provide up-to-date epidemiological evidence on the uptake of LAIV and its impact on HCRU related to ILI in children in England. This may be used by the NHS for planning and evaluation of the childhood influenza vaccination program.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAIV Vaccinated cohort | – | –All individuals receiving LAIV between 2 and <18 years within a given flu season between 2012 and 2020. |
| Unvaccinated cohort | – | –All individuals between 2 and <18 years with no record of influenza vaccinations in a given flu season |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will include all research eligible children born between the 1st January 1994 and 31st August 2020 (latest date at which a child can be aged 2 years or above in the study period and have at least six months follow up in the most recent data), with 6 months of medical history available in CPRD before their the 1st September in the first year they are aged 2 years or above. The childhood influenza programme has been conducted on a rolling basis since 2013. Classification of each child as eligible for the vaccine will therefore vary year on year depending on their age, GP practice location and presence of high-risk conditions.
Key inclusion criteria (2 listed)
- Aged ≥6 months and <2 years on the 1st September
- Have a high-risk condition as listed in the Green Book.
Key exclusion criteria (2 listed)
- Were deceased or had migrated out of their practice prior to the 1st September in the current influenza season.
- Were recorded has receiving both QIV and LAIV in the current influenza season.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uptake of influenza vaccination
Time frame: Per flu season (defined as 1st September in a given year to the 30th April the following year )
Proportion of eligible individuals receiving a flu vaccine (LAIV, QIV, other)
8 secondary outcomes
GP consultations for ILI (influenza-like illness)
Time frame: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Laboratory confirmed influenza
Time frame: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Admitted Patient Care (APC) episodes associated with ILI
Time frame: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Accident and Emergency (A&E) attendances associated with ILI
Time frame: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Outpatient attendances associated with ILI
Time frame: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Length of stay in APC for influenza and ILI
Time frame: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Number of antibiotic prescriptions
Time frame: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
Number of antiviral prescriptions
Time frame: From vaccination date until the earliest of death, de-registration, or the end of the influenza season (30th April of the second calendar year the season spans).
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 27 Apr 2025.
- redacted CSR SynopsisLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AstraZeneca 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 2 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 27 Apr 2025. 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?
Uptake of influenza vaccination (time frame: Per flu season (defined as 1st September in a given year to the 30th April the following year )). 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 27 Apr 2025.