Last updated: 11/07/2018 11:28:15

Study to assess the burden of mild outcomes (physician office visits) due to influenza in the United States

GSK study ID
117233
See study documents
Clinicaltrials.gov ID
NCT02019732
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Burden of mild outcomes due to influenza in the United States, July 2000 through April 2009 and October 2010 to May 2011
Trial 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
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
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    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.
    Medical condition
    Influenza
    Product
    GSK2321138A
    Collaborators
    Not applicable
    Study date(s)
    January 2013 to June 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Recorded in a Marketscan database with any of the specified diagnostic codes.
    • Missing data in any of the following fields: age, diagnosis, region or visit date.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bethesda, Maryland, United States, 20814
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-30-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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