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

Not Applicable

Completed

• Conditions: Influenza; Respiratory; Influenza, virus not identified

• Registration Number: ISRCTN88072400
• Lead Sponsor: Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)

Brief Summary

2017 protocol in https://pubmed.ncbi.nlm.nih.gov/28246142/ (added 23/10/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/33256892/ (added 12/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-17
• Study Completion: 2017-04-01
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1250000

Inclusion Criteria

All (anonymised) patient data will be collected

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Influenza positivity from virological swab data in vaccinated and unvaccinated patients stratified by ?at-risk? populations, age, sex and socioeconomic status

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br>