Infections, Rotavirus Clinical Trial
Official title:
Clinical and Cost Impact of Complete and Incomplete Rotavirus Vaccination
This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq® and Rotarix®) 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 RV vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months, 8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).
Insurance claims data from the MarketScan Commercial Claims and Encounters Database
{MarketScan Commercial (2000-2011[Q2])} and the MarketScan Multi-State Medicaid Database
{Marketscan Medicaid (2002-2010)} 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).
For children who received at least 1 RV vaccine dose within the Advisory Committee on
Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old, their
observation time will be divided into three RV-vaccinated cohorts: any RV vaccination before
8 months (i.e., during the vaccination window between 6 weeks and 8 months old); complete RV
vaccination (i.e., after 8 months old); and incomplete RV vaccination (i.e., after 8 months
old). For children who did not receive any RV vaccine dose within the vaccination window,
their observation time will be divided into four control cohorts: historical (i.e., before
RV vaccines were available) unvaccinated on/before 8 months old; contemporary (i.e., after
RV vaccines were available) unvaccinated on/before 8 months old; historical unvaccinated
after 8 months old; and contemporary unvaccinated after 8 months old.
;
Observational Model: Cohort, Time Perspective: Retrospective
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