Infections, Rotavirus Clinical Trial
Official title:
Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
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:
1. Rotarix vaccination according to compliance with the Advisory Committee on Immunization
Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old.
2. Rotarix vaccination according to compliance with the Rotarix prescribing information
(PI) window of 6 weeks to 6 months old.
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.
;
Observational Model: Cohort, Time Perspective: Retrospective
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