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
Study complete
Study complete
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:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
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)
This study does not involve prospective enrollment of participants.
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
Study complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website