Status:
COMPLETED
Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Analysis Group, Inc.
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
Up to 5 years
Brief Summary
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 populat...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Continuously enrolled from birth. (Note: Due to the absence of birth dates in insurance claims data, this inclusion criterion will be met if a child's year of first enrollment and year of birth are the same. If so, then the date of first enrollment will be used as proxy for date of birth.)
- Received both medical and pharmacy benefits.
Exclusion
- Enrolled in capitation-based health plans.
- For MarketScan Commercial, residence in states with universal vaccination programs that include the RV vaccine or where RV vaccine inclusion cannot be ascertained (i.e., Alaska, Idaho, Massachusetts, Maine, North Dakota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming).
- Received any Rotateq vaccination.
- Lost to follow-up prior to end of vaccination window or had RV prior to end of vaccination window.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01915888
Start Date
August 1 2013
End Date
February 1 2014
Last Update
November 17 2014
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