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NCT00875641 · ClinicalTrials.gov registry record
Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
A clinical trial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 390,659
- Enrollment target
NCT00875641: Completed study, sponsored by GlaxoSmithKline.
NCT00875641 is a clinical trial that has completed, run by GlaxoSmithKline. The registered enrollment target is 390,659 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00875641 has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 390,659 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Interventions
- OTHER Health Insurance Database
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390,659 participants |
| Start Date | 2009-04-20 |
| Est. Completion | 2016-11-04 |
What the finished NCT00875641 record still lists
NCT00875641 is an observational study that tracks outcomes without assigning an intervention. Its 390,659 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Health Insurance Database is the first listed.
NCT00875641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00875641 about?
NCT00875641 is a clinical study titled "Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States". 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 lif...
What is the current status of trial NCT00875641?
This trial is currently completed. The enrollment target is 390,659 participants. The study started on 2009-04-20. Estimated completion is 2016-11-04.
What interventions are being tested in trial NCT00875641?
The interventions under investigation include: Health Insurance Database (OTHER).
Who is sponsoring clinical trial NCT00875641?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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