Study to Assess the Burden of Mild Outcomes (Physician Office Visits) Due to Influenza in the United States

Influenza Clinical Trial

Official title:

Burden of Mild Outcomes Due to Influenza in the United States, July 2000 Through April 2009 and October 2010 to May 2011

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019732
• Other study ID #: 117233
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: January 9, 2017
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial Summary

This is a database study to quantify the burden of multiple mild outcomes (i.e., those that result in visits to a physician's office) attributable to influenza in the United States, stratified by age group, geographic region and influenza subtype for selected influenza seasons.

Description:

This is a retrospective database study to quantify the burden of multiple mild pre-defined influenza-attributable outcomes of interest, which resulted in physician office visits for persons who were less than 65 years of age, in the United States in the relevant Marketscan Commercial database in the period from July 2000 through April 2009, and October 2010 to May 2011. The corresponding physician office visits for persons 65 years of age and older, with a mild influenza-attributable outcome of interest, in the United States that were recorded in the relevant MarketScan Medicare Supplemental database in the period from July 2006 through April 2009, and October 2010 to May 2011 were also investigated. The period from April 2009 through September 2010 is excluded to avoid the H1N1 pandemic wave.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Recorded in a Marketscan database with any of the specified diagnostic codes.

Exclusion Criteria:

• Missing data in any of the following fields: age, diagnosis, region or visit date.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Other:
• Data collection
Data collection from existing electronic healthcare databases (Marketscan Commercial database, MarketScan Medicare Supplemental database).

Locations

Country	Name	City	State
United States	GSK Investigational Site	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly occurrences of potentially influenza-attributable physician's office visits by age, region and season.	- All the events contained within "potentially influenza-attributable" office visits. - Weekly proportion of circulating influenza A and B strains determined for each season.	Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).	No
Secondary	Assessment of Influenza vaccine content and effectiveness by season.		Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).	No
Secondary	Assessment of Influenza vaccine coverage by season and region.		Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).	No
Secondary	Assessment of Influenza B vaccine mismatch (by region and season).		Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).	No