Status:
COMPLETED
Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
Up to 1 years
Brief 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...
Eligibility Criteria
Inclusion
- For Exposed cohort:
- Infants aged less than 1 year at study entry.
- Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- Have complete medical coverage and pharmacy benefits.
- Received at least one dose of Rotarix from 1 August 2008.
- Infants receiving Rotarix liquid formulation will also be eligible.
- For Unexposed cohort A:
- Infants aged less than 1 year at study entry.
- Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- Have complete medical coverage and pharmacy benefits.
- Received at least one dose of IPV vaccine from 1 August 2008, with or without RotaTeq vaccination.
- Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination within the same year.
- For Unexposed cohort B:
- Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
- Had complete medical coverage and pharmacy benefits.
- Received at least one dose of IPV vaccine.
- Vaccinated between 1 January 2006 (inclusive) and 31 July 2008 (inclusive).
- Not received any dose of rotavirus vaccination.
- Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination.
Exclusion
- 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.
Key Trial Info
Start Date :
April 20 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 4 2016
Estimated Enrollment :
390659 Patients enrolled
Trial Details
Trial ID
NCT00875641
Start Date
April 20 2009
End Date
November 4 2016
Last Update
January 25 2019
Active Locations (1)
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1
GSK Investigational Site
Waltham, Massachusetts, United States, 02451