Completed

Study Description:

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.

GSK Study ID:

117233


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT02019732


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Influenza

Product

GSK2321138A

Collaborators

N/A


Date

January 2013 to June 2013

Type

Observational

Phase

N/A


Gender

Both

Age

N/A - N/A

Accepts Healthy Volunteers

No


Study Documents

This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

United States, Maryland, Bethesda 20814Completed

Study Design

  • Primary Purpose: Not Available
  • Allocation: Not Available
  • Study Design: Not Available
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Not Available
  • Masked Caregiver: Not Available
  • Masked Investigator: Not Available
  • Masked Assessor: Not Available
Primary Outcomes:

  • Weekly occurrences of potentially influenza-attributable physician’s office visits by age, region and season.
    Timeframe: Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).

Secondary Outcomes:

  • Assessment of Influenza vaccine content and effectiveness by season.
    Timeframe: 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.
    Timeframe: 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).
    Timeframe: Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).

Interventions:

  • Other: Data collection

Keyword:

  • Mild outcomes, Database, Influenza-attributable, Retrospective, Influenza, United States of America (USA)
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 1

Clinical Publications:

  • Matias G et al. (2016) Model estimates of the burden of outpatient visits attributable to influenza in the United States. BMC Infect Dis.16(1):641.