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

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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).




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). ]


Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019732


Locations
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United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02019732     History of Changes
Other Study ID Numbers: 117233
First Posted: December 24, 2013    Key Record Dates
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:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases