Clinical Trial

The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants

Study acronym: Rota5DCHILE
Active, Not Recruiting Phase 3
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Summary
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks. A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-01-09.
Status change: Recruiting → Active, Not Recruiting 2025-05-19
Trial Details
NCT Number NCT06200844
Lead Sponsor Bharat Biotech International Limited
Conditions Rotavirus Infection of Children
Enrollment 5,800 participants
Start Date 2023-07-07
Primary Completion 2025-01-04 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-05-22