Influenza Burden Assessment in the United States, July1997 - up to April 2009
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Burden of Influenza in the United States, July 1997 up to April 2009|
- Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season. [ Time Frame: 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. [ Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years) ]
- Influenza vaccine content and effectiveness by season. [ Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years) ]
- Influenza vaccine coverage by season. [ Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years) ]
|Study Start Date:||July 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Other: Data collection
The study will use multiple primary data sources: the Nationwide Inpatient Sample (for hospitalisations) and the US National Vital Statistics System (for mortality), and weekly virology data from the Centers for Disease Control and Prevention (CDC) influenza surveillance program supplemented with literature data.
Weekly time series of the rates of various severe influenza-related health outcomes will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the CDC virology data, will be constructed to estimate the portions of the various outcomes that can be attributed to influenza. Next, the seasonal impact of influenza by age, risk status, and influenza subtype will be assessed. Finally, the potential burden that a quadrivalent vaccine could have prevented over the 12 year study period will be predicted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599390
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|