Last updated: 11/07/2018 10:22:41
Burden of respiratory syncytial virus (RSV) in the United Kingdom from 1995 to 2009
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Burden of respiratory syncytial virus (RSV) in the United Kingdom, 1995 to 2009
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes.
Timeframe: From 1995 to 2009
Secondary outcomes:
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.
Timeframe: 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.
Timeframe: From 1995 to 2009
Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.
Timeframe: 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.
Timeframe: From 1995 to 2009
Interventions:
Other: Data collection
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Fleming DM et al. (2015) Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis.15(443):1-12.
Taylor S et al. (2016) Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK. BMJ Open. 6(6):e009337.
Medical condition
Respiratory Syncyctial Virus Vaccines
Product
GSK2647160A
Collaborators
Sage Analytica
Study date(s)
October 2012 to November 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Included in the EPI-FLU-018 BOD UK DB BOD UK DB (eTrack: 116273) study database. The inclusion criterion for EPI-FLU-018 was registration with an acceptable flag in the CPRD, or registration in the HES database or the ONS mortality data with a flu-related event.
- Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:
Included in the EPI-FLU-018 BOD UK DB BOD UK DB (eTrack: 116273) study database. The inclusion criterion for EPI-FLU-018 was registration with an acceptable flag in the CPRD, or registration in the HES database or the ONS mortality data with a flu-related event.
Exclusion criteria:
Not Applicable
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-30-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website