Influenza Burden Assessment in the United States, July1997 - up to April 2009

Influenza Clinical Trial

Official title:

Burden of Influenza in the United States, July 1997 up to April 2009

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599390
• Other study ID #: 116730
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: February 21, 2013
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. Data will be extracted from existing electronic healthcare databases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Sage Analytica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season.		From July 1997 to April 2009 (i.e., up to almost 12 years)	No
Primary	Amount of circulating influenza A and B, and RSV strains determined for each season.		From July 1997 to April 2009 (i.e., up to almost 12 years)	No
Secondary	Influenza vaccine content and effectiveness by season.		From July 1997 to April 2009 (i.e., up to almost 12 years)	No
Secondary	Influenza vaccine coverage by season.		From July 1997 to April 2009 (i.e., up to almost 12 years)	No