Clinical Trial

The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)

Completed Phase 1
View on ClinicalTrials.gov →
Summary
The Phase I clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in a population ranging from 6 weeks to 59 years of age. The objective of this study is to evaluate the safety of investigational vaccine in healthy adults and children, as well as its safety tolerability, and immunogenicity in healthy infants. The study will be an open-label observation in adults and children, and a randomized, double-blind, placebo-controlled clinical trial in infants.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-22; most recent amendment 2026-03-17.
Status change: Active, Not Recruiting → Completed 2026-03-17
Trial Details
NCT Number NCT06950645
Lead Sponsor Sinovac Life Sciences Co., Ltd.
Conditions Rotavirus Gastroenteritis
Enrollment 100 participants
Start Date 2024-03-27
Primary Completion 2024-12-21 (estimated)
Study Completion 2025-12-18 (estimated)
Updated on ClinicalTrials.gov 2026-03-20