NCT00875641

Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States

Safety Study of GSK Biologicals' Rotarix® (Rotavirus Vaccine, Live, Oral) Administered to a Birth Cohort in United States Health Insurance Plans

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 390,659 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
OTHER	Health Insurance Database	Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.

Timeline

• Start date: 2009-04-20
• Primary completion: 2016-11-04
• Completion: 2016-11-04
• First posted: 2009-04-03
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

1 site across 1 country: United States