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OpenTrials
Completed

NCT Number: NCT02019732

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Bethesda, Maryland, 20814, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2013
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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