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

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.

NCT Number	NCT07611513
Lead Sponsor	Sinovac Biotech Co., Ltd
Conditions	Hand, Foot, and Mouth Disease(HFMD), Herpangina
Enrollment	6,000 participants
Start Date	2026-05
Primary Completion	2027-12 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2026-05-28