drugset / Trial / NCT07611513

Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).

NCT07611513 ↗

Phase 3 Not yet recruiting 6000 enrolled Sinovac Biotech Co., Ltd
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months. Participants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.

Timeline

Start
2026-05
Primary completion
2027-12
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) Vaccine — Intramuscular