NCT01520935

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

January 23, 2012

Last Update Submit

September 6, 2012

Conditions

Influenza

Keywords

Office of National StatisticsBurden of DiseaseInfluenzaHospital Episode StatisticsGeneral Practitioners Research Database

Outcome Measures

Primary Outcomes (4)

  • Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza

    From 1996 to 2008 (up to 13 years)

  • Relative impact of influenza on high versus low risk populations

    From 1996 to 2008 (up yo 13 years)

  • Relative impact of influenza during match versus mismatched seasons

    From 1996 to 2008 (up to 13 years)

  • Relative impact of influenza on vaccinated versus unvaccinated populations

    From 1996 to 2008 (up to 13 years)

Study Arms (1)

Cohort Group

Other: Data collection

Interventions

Data collectionOTHER

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Matias G, Taylor RJ, Haguinet F, Schuck-Paim C, Lustig RL, Fleming DM. Modelling estimates of age-specific influenza-related hospitalisation and mortality in the United Kingdom. BMC Public Health. 2016 Jun 8;16:481. doi: 10.1186/s12889-016-3128-4.

    PMID: 27278794DERIVED

  • Fleming DM, Taylor RJ, Haguinet F, Schuck-Paim C, Logie J, Webb DJ, Lustig RL, Matias G. Influenza-attributable burden in United Kingdom primary care. Epidemiol Infect. 2016 Feb;144(3):537-47. doi: 10.1017/S0950268815001119. Epub 2015 Jul 13.

    PMID: 26168005DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 30, 2012

Study Start

September 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 10, 2012

Record last verified: 2012-09