Influenza Burden Assessment in the United Kingdom, 1996-2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Influenza |
Other: Data collection |
| Study Type: | Observational |
| 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 ]
| Enrollment: | 1 |
| Study Start Date: | September 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Cohort Group |
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. |
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
People of any age in the United Kingdom who were registered with an acceptable flag in the GPRD, or with a potentially influenza-related event in the HES database or the ONS mortality data.
Inclusion Criteria:
• Registration with an acceptable flag in the GPRD, or registration with a potentially influenza-related event in the HES database or the ONS mortality data.
Exclusion Criteria:
-
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01520935 History of Changes |
| Other Study ID Numbers: | 116273 |
| Study First Received: | January 23, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
Office of National Statistics Burden of Disease Influenza Hospital Episode Statistics General Practitioners Research Database |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013