drugset / Trial / NCT06950645

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

NCT06950645 ↗

Phase 1 Completed 100 enrolled Sinovac Life Sciences Co., Ltd.
RandomizedSequentialQuadruple-blindPrevention

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.

Timeline

Start
2024-03-27
Primary completion
2024-12-21
Completion
2025-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Oral hexavalent reassortant rotavirus attenuated live vaccine Vaccine — Oral

Indications