Infections, Rotavirus Clinical Trial
Official title:
Safety Study of GSK Biologicals' Rotarix® (Rotavirus Vaccine, Live, Oral) Administered to a Birth Cohort in United States Health Insurance Plans
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.
n/a
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|---|---|---|---|
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| Completed |
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| Completed |
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||
| Completed |
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Phase 3 | |
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Phase 3 | |
| Completed |
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N/A | |
| Completed |
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||
| Completed |
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Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
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||
| Completed |
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|
Phase 3 | |
| Completed |
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Phase 2 | |
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Phase 2 | |
| Completed |
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|
Phase 2 | |
| Completed |
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N/A | |
| Completed |
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N/A |