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NCT01520935 Clinical Trial

Influenza Burden Assessment in the United Kingdom, 1996-2008

Influenza Clinical Trial

Official title:
Burden of Influenza in the United Kingdom, 1996-2008

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01520935
Other study ID # 116273
Secondary ID
Status Completed
Phase N/A
First received January 23, 2012
Last updated September 6, 2012
Start date September 2011
Est. completion date May 2012

Study information
Verified date September 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
GlaxoSmithKline Sage Analytica

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza From 1996 to 2008 (up to 13 years) No
Primary Relative impact of influenza on high versus low risk populations From 1996 to 2008 (up yo 13 years) No
Primary Relative impact of influenza during match versus mismatched seasons From 1996 to 2008 (up to 13 years) No
Primary Relative impact of influenza on vaccinated versus unvaccinated populations From 1996 to 2008 (up to 13 years) No
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