Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
Launched by GLAXOSMITHKLINE · Apr 2, 2009
Trial Information
Current as of May 10, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- 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 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.
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Waltham, Massachusetts, United States
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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