An observational study in Infections, Rotavirus, sponsored by GlaxoSmithKline. Completed. Open to participants aged Up to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-17.
Sponsored by GlaxoSmithKline · Observational
This study aims to estimate the clinical and cost impact of Rotarix vaccinations among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population. The impact of incomplete and complete Rotarix vaccination will also be examined, overall and stratified by calendar time of Rotarix vaccination (e.g., 2008 onward).
Insurance claims data from the MarketScan Commercial Claims and Encounters Database {MarketScan Commercial (2000-2010)} and the MarketScan Multi-State Medicaid Database {MarketScan Medicaid (2002-2009)} will be analyzed separately; no merging of the databases will occur.
The claims data extracts are fully de-identified and compliant with the Health Insurance Portability and Accountability Act of 1996 (U.S.) (HIPAA).
The children will be observed from birth to the earliest of end of continuous eligibility (due to disenrollment, data cut-off, or death) or 5 years of age. Observation time will be classified using two different definitions of Rotarix vaccination coverage, and analyses will be conducted for each different scenario.
The two definitions for Rotarix vaccination coverage are:
All outcomes will be analysed for 1) vaccination coverage according to compliance with the ACIP vaccination window, and 2) vaccination coverage according to compliance with PI vaccination window; for both Rotarix vaccination coverage scenarios there will be four cohorts.
An additional 'complete Rotarix vaccination off-ACIP/off-PI' cohort will be created if more than 5 percent of total person-time in the four cohorts would be complete vaccination if vaccine doses outside of the vaccination window were considered.
101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's enrollment of 1 is below the median of 885 across 31 observational studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children less than 5 years old continuously enrolled in commercial insurance or Medicaid from birth, and received both medical and pharmacy benefits.
Exclusion Criteria:
Subjects had received 2 doses of Rotarix within the vaccination window and the observation time is from the end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario) to end of observation.
Other: Data interpretation
Subjects had received one vaccination of Rotarix within the vaccination window and the observation time is from end of vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario)(if still observed) to end of observation.
Other: Data interpretation
Subjects did not receive any Rotarix vaccine dose within the vaccination window and the observation time is from end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario, if vaccination window ends on/before 12/31/2006) to end of observation.
Other: Data interpretation
Subjects did not receive any Rotarix vaccine dose within the vaccination window and the observation time is from end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario, if vaccination window ends after 1/1/2007) to end of observation.
Other: Data interpretation
The data collected for each group will be fully de-identified, interpreted and analysed separately for the 2 databases (MarketScan Commercial and MarketScan Medicaid).
Incidence of first RV episode
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
Time frame: During the study period (from 2000 up to 2010)
Incidence of RV-related utilization
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
Time frame: During the study period (from 2000 up to 2010)
Incidence of diarrhea-related utilization
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
Time frame: During the study period (from 2000 up to 2010)
No study locations are listed for this record.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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