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Completed

NCT Number: NCT01520935

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Data Collection

Other

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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Sage Analytica

Registry information

Official study title

Burden of Influenza in the United Kingdom, 1996-2008

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 30, 2012
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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