This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of intussusception with Rotarix within 60 days of vaccination in a real life setting (routine use) in the US. This study will also include monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory tract infections and all-cause deaths within 60-days of vaccination. This study involves three cohorts, one exposed and two control cohorts: infants who receive Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B). This is a combined prospective and retrospective cohort study. Prospective component of the study identifies and compares study outcomes following Rotarix and IPV vaccination in the Exposed cohort and Unexposed cohort A, respectively. Retrospective component of the study identifies and compares study outcomes following IPV vaccination in the Unexposed cohort B.
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Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts
Timeframe: 60 days following each vaccination
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
Timeframe: 7 days following each vaccination
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
Timeframe: 30 days following each vaccination