Early estimation of pandemic influenza Antiviral and Vaccine Effectiveness (EAVE) - use of a unique community and laboratory national linked dataset

Early estimation of pandemic influenza Antiviral and Vaccine Effectiveness (EAVE) - use of a unique community and laboratory national linked dataset: an observational longitudinal cohort study with nested-case control study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN55398410

Enrollment

300000

Registered

2013-02-08

Start date

2013-01-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pandemic influenza Respiratory Influenza A/H1N1 pandemic 2009 [swine flu]

Interventions

No intervention will be given to patients. Any pandemic influenza vaccine programmes implemented in Scotland will be assessed for effectiveness.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All (anonymised) patient data will be collected

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
The vaccination uptake in the relevant ?at risk? populations (patients 65 years) and the general population recorded by general practices	—

Secondary

Measure	Time frame
1. Influenza positivity from virological swab data in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socioeconomic status. 2. Influenza positivity from serology data in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socioeconomic status, which will permit the estimation of incidence of influenza. 3. Consultation for influenza-related morbidity (e.g. influenza, pneumonia, chronic obstructive pulmonary disease [COPD] and cardiac related consultations) and issue of antiviral therapy from general practice data in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socio-economic status 4. Mortality and influenza-related serious morbidity (e.g. influenza, pneumonia, COPD and cardiac related death and hospitalisation from SMR01 records) in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socioeconomic status 5. For patients with stored serology (and prior to the introduction of any vaccination) whether cross-reactivity occurs due to previous exposure to A/H1N1 or A/H1N1 vaccination, other pandemic influenza or other seasonal influenza vaccination or exposure.	—

Measure

Time frame

1. Influenza positivity from virological swab data in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socioeconomic status. 2. Influenza positivity from serology data in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socioeconomic status, which will permit the estimation of incidence of influenza. 3. Consultation for influenza-related morbidity (e.g. influenza, pneumonia, chronic obstructive pulmonary disease [COPD] and cardiac related consultations) and issue of antiviral therapy from general practice data in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socio-economic status 4. Mortality and influenza-related serious morbidity (e.g. influenza, pneumonia, COPD and cardiac related death and hospitalisation from SMR01 records) in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socioeconomic status 5. For patients with stored serology (and prior to the introduction of any vaccination) whether cross-reactivity occurs due to previous exposure to A/H1N1 or A/H1N1 vaccination, other pandemic influenza or other seasonal influenza vaccination or exposure.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026