NCT01706302

Brief Summary

The study will assess the burden of RSV-attributable general practice consultations, hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.

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 Oct 2012

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

October 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2013

Enrollment Period

1 month

First QC Date

October 11, 2012

Last Update Submit

April 25, 2013

Conditions

Respiratory Syncyctial Virus Vaccines

Keywords

General Practice Research DatabaseBurden of DiseaseClinical Practice Research DatalinkHospital Episode StatisticsOffice of National StatisticsRSV

Outcome Measures

Primary Outcomes (1)

  • Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes.

    From 1995 to 2009

Secondary Outcomes (4)

  • Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with non-respiratory outcomes.

    From 1995 to 2009

  • Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP prescription of antibiotics relevant to respiratory disease, by age and risk group.

    From 1995 to 2009

  • Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.

    From 1995 to 2009

  • Occurrence of potentially RSV-attributable deaths among the total number of RSV-attributable hospitalizations and cases, by age and risk group.

    From 1995 to 2009

Study Arms (1)

Cohort Group

Other: Data collection

Interventions

Data collectionOTHER

The previous study has used four primary data sources: the General Practice Research Data (GPRD \[recently re-named Clinical Practice Research Datalink (CPRD)\], 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). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group.

Cohort Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects included in the 116273 study who were registered with an acceptable flag in the CPRD, or with a potentially RSV-related event in the HES database or the ONS mortality data.

You may not qualify if:

  • Not Applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Taylor S, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Fleming DM. Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK. BMJ Open. 2016 Jun 2;6(6):e009337. doi: 10.1136/bmjopen-2015-009337.

    PMID: 27256085DERIVED

  • Fleming DM, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Taylor S. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis. 2015 Oct 23;15:443. doi: 10.1186/s12879-015-1218-z.

    PMID: 26497750DERIVED

MeSH Terms

Interventions

Data Collection

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

October 11, 2012

First Posted

October 15, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 29, 2013

Record last verified: 2013-04