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Trial record 1 of 1 for:    NCT02019732
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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

Tracking Information
First Submitted Date November 27, 2013
First Posted Date December 24, 2013
Last Update Posted Date January 10, 2017
Study Start Date January 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02019732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 19, 2013)
  • 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). ]
  • 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). ]
  • 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). ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Assess the Burden of Mild Outcomes (Physician Office Visits) Due to Influenza in the United States
Official Title Burden of Mild Outcomes Due to Influenza in the United States, July 2000 Through April 2009 and October 2010 to May 2011
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.
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Influenza
Intervention Other: Data collection
Data collection from existing electronic healthcare databases (Marketscan Commercial database, MarketScan Medicare Supplemental database).
Study Groups/Cohorts 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.
Intervention: Other: Data collection
Publications * Matias G, Haguinet F, Lustig RL, Edelman L, Chowell G, Taylor RJ. Model estimates of the burden of outpatient visits attributable to influenza in the United States. BMC Infect Dis. 2016 Nov 7;16(1):641.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 19, 2013)
1
Original Actual Enrollment Same as current
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02019732
Other Study ID Numbers 117233
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date January 2017