Rotavirus Clinical Trial
Official title:
V260-027 Safety and Immunogenicity of RotaTeq™ in Elderly Subjects
This is a Phase I clinical trial including 2 parts to evaluate the safety and immune
response to RotaTeq™ /placebo in subjects of 65 to 80 years of age. In Part I, approximately
60 subjects in US will be randomly assigned to 1 of 2 treatment groups receiving 3 doses of
RotaTeq™ or placebo. In Part II, approximately 200 subjects internationally will be randomly
assigned to 1 of 3 treatment groups. Part II will start after Part I data analysis is
reviewed and approved by the FDA/CBER, the Safety Evaluation Committee (SEC) and other
regulatory agencies. Duration for the entire study will be approximately 4 years.
Note: As the result of a business decision by the Sponsor, the study did not proceed with
Part II. Therefore, this report includes the results for Part I only.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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