Influenza Burden Assessment in the United Kingdom, 1996-2008
The study will assess the burden of influenza by age, risk status, vaccination status and influenza subtype, in order to create a complete profile of the burden of influenza-related morbidity and mortality in United Kingdom from 1996 to 2008.
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Burden of Influenza in the United Kingdom, 1996-2008|
- Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza [ Time Frame: From 1996 to 2008 (up to 13 years) ] [ Designated as safety issue: No ]
- Relative impact of influenza on high versus low risk populations [ Time Frame: From 1996 to 2008 (up yo 13 years) ] [ Designated as safety issue: No ]
- Relative impact of influenza during match versus mismatched seasons [ Time Frame: From 1996 to 2008 (up to 13 years) ] [ Designated as safety issue: No ]
- Relative impact of influenza on vaccinated versus unvaccinated populations [ Time Frame: From 1996 to 2008 (up to 13 years) ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Other: Data collection
The study, will use four primary data sources: the General Practice Research Database (GPRD, for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA).
Weekly time series of the rates of various influenza-related health outcomes in the various databases, such as office visits for acute otitis media and hospitalizations for pneumonia will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the HPA virology data, to estimate the portions of the various outcomes that can be attributed to influenza will be constructed. Finally, the seasonal impact of influenza by risk status, vaccination status, and seasons in which a well-matched versus mismatched influenza vaccine was used, will be assessed.
This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. The data collection will be a query of existing electronic healthcare databases.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520935
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|