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

• ClinicalTrials.gov Identifier: NCT02019732
• Recruitment Status: Completed
• First Posted: December 24, 2013
• Last Update Posted: January 10, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Influenza	Other: Data collection

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Time Perspective: Retrospective
• Official Title: Burden of Mild Outcomes Due to Influenza in the United States, July 2000 Through April 2009 and October 2010 to May 2011
• Study Start Date: January 2013
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
Study Group; Applicable subjects less than 65 years of age identified in the Marketscan Commercial database during the period from July 2000 through April 2009, and October 2010 to May 2011 and subjects 65 years of age and older identified in MarketScan Medicare Supplemental database during the period from July 2006 through April 2009, and October 2010 to May 2011.	Other: Data collection; Data collection from existing electronic healthcare databases (Marketscan Commercial database, MarketScan Medicare Supplemental database).

Outcome Measures

Primary Outcome Measures :

1. Weekly occurrences of potentially influenza-attributable physician's office visits by age, region and season. [ Time Frame: Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database). ]
   - All the events contained within "potentially influenza-attributable" office visits. - Weekly proportion of circulating influenza A and B strains determined for each season.

Secondary Outcome Measures :

1. Assessment of Influenza vaccine content and effectiveness by season. [ Time Frame: Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database). ]
2. Assessment of Influenza vaccine coverage by season and region. [ Time Frame: Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database). ]
3. Assessment of Influenza B vaccine mismatch (by region and season). [ Time Frame: Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database). ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All records related to physician office visits of subjects less than 65 years of age and 65 years of age and older in the United States with an outcome of interest in the relevant Marketscan database.

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

GSK Investigational Site

Bethesda, Maryland, United States, 20814

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Matias G, Haguinet F, Lustig RL, Edelman L, Chowell G, Taylor RJ. Model estimates of the burden of outpatient visits attributable to influenza in the United States. BMC Infect Dis. 2016 Nov 7;16(1):641.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02019732
• Other Study ID Numbers: 117233
• First Posted: December 24, 2013
• Last Update Posted: January 10, 2017
• Last Verified: January 2017

Keywords provided by GlaxoSmithKline:

Mild outcomes; Database; Influenza-attributable; Retrospective; Influenza; United States of America (USA)

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases