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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02019732

Enrollment

Registered

2013-12-24

Start date

2013-01-31

Completion date

2013-06-30

Last updated

2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

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

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.

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.

Interventions

OTHERData collection

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

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Weekly occurrences of potentially influenza-attributable physician's office visits by age, region and season.	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

Measure	Time frame
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).
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).
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026