Last updated: 11/07/2018 10:46:05
Influenza Burden assessment in the United States, July1997 – up to April 2009
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Burden of Influenza in the United States, July 1997 up to April 2009
Trial description: The study will assess the burden of severe influenza outcomes by age, risk status, and influenza subtype, in order to create a profile of the burden of influenza-related morbidity and mortality in United States from July 1997 to April 2009.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season.
Timeframe: From July 1997 to April 2009 (i.e., up to almost 12 years)
Amount of circulating influenza A and B, and RSV strains determined for each season.
Timeframe: From July 1997 to April 2009 (i.e., up to almost 12 years)
Secondary outcomes:
Influenza vaccine content and effectiveness by season.
Timeframe: From July 1997 to April 2009 (i.e., up to almost 12 years)
Influenza vaccine coverage by season.
Timeframe: From July 1997 to April 2009 (i.e., up to almost 12 years)
Interventions:
Other: Data collection
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Bekkat-Berkani R et al. (2016) Evidence update: GlaxoSmithKline’s inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 15(2):201-214.
Matias G et al. (2014) Estimates of mortality attributable to influenza and RSV in the United States during 1997-2009 by influenza type or subtype, age, cause of death, and risk status. Influenza Other Respir Viruses. 8(5):507-515.
Matias G et al. (2017) Estimates of hospitalization attributable to influenza and RSV in the US during 1997-2009, by age and risk status. BMC Public Health. 17(1):271.
Medical condition
Influenza
Product
GSK2647158A
Collaborators
Sage Analytica
Study date(s)
July 2012 to September 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.
- Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).
Inclusion and exclusion criteria
Inclusion criteria:
- Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.
Exclusion criteria:
- Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).
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
2012-01-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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