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
  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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520935

Sponsors and Collaborators
GlaxoSmithKline
Sage Analytica
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  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 July 22, 2014