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Influenza Burden Assessment in the United Kingdom, 1996-2008

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ClinicalTrials.gov Identifier: NCT01520935
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Sage Analytica
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment
Influenza Other: Data collection

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.

Study Type : Observational
Actual Enrollment : 1 participants
Time Perspective: Retrospective
Official Title: Burden of Influenza in the United Kingdom, 1996-2008
Study Start Date : September 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
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.





Primary Outcome Measures :
  1. Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza [ Time Frame: From 1996 to 2008 (up to 13 years) ]
  2. Relative impact of influenza on high versus low risk populations [ Time Frame: From 1996 to 2008 (up yo 13 years) ]
  3. Relative impact of influenza during match versus mismatched seasons [ Time Frame: From 1996 to 2008 (up to 13 years) ]
  4. Relative impact of influenza on vaccinated versus unvaccinated populations [ Time Frame: From 1996 to 2008 (up to 13 years) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520935


Sponsors and Collaborators
GlaxoSmithKline
Sage Analytica
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01520935     History of Changes
Other Study ID Numbers: 116273
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: September 2012

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