Influenza Burden Assessment in the United Kingdom, 1996-2008

This study has been completed.
Sponsor:
Collaborator:
Sage Analytica
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01520935
First received: January 23, 2012
Last updated: September 6, 2012
Last verified: September 2012

January 23, 2012
September 6, 2012
September 2011
May 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01520935 on ClinicalTrials.gov Archive Site
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Influenza Burden Assessment in the United Kingdom, 1996-2008
Burden of Influenza 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.

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.

Observational
Time Perspective: Retrospective
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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.

Influenza
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.

Cohort Group
Intervention: Other: Data collection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
May 2012
May 2012   (final data collection date for primary outcome measure)

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:

-

Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01520935
116273
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GlaxoSmithKline
GlaxoSmithKline
Sage Analytica
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP