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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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Inclusion criteria
For Exposed cohort:
For Unexposed cohort A:
For Unexposed cohort B:
Exclusion criteria
For Exposed cohort:
• Subject has received any dose of RotaTeq prior to the first Rotarix vaccine during the study period.
For Unexposed cohort A:
• Subject has received any dose of Rotarix prior to the first IPV vaccine during the study period.
For Unexposed cohort B:
• Subject has received any dose of rotavirus vaccines prior to the first IPV vaccine.
390,659 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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