SIVE II: an evaluation of the seasonal influenza vaccine using routine data sources

Seasonal Influenza Vaccination Effectiveness II (SIVE II): use of a large national primary care and laboratory-linked dataset to evaluate live attenuated and trivalent inactivated influenza vaccination effectiveness

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN88072400

Enrollment

2000000

Registered

2014-11-17

Start date

2014-10-01

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

Influenza Respiratory Influenza, virus not identified

Interventions

16 influenza vaccine programmes implemented in Scotland will be evaluated 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
Influenza positivity from virological swab data in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socioeconomic status	—

Secondary

Measure	Time frame
1. 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 2. 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	—

Measure

Time frame

1. 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 2. 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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026