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Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Sponsor: Sinovac Biotech Co., Ltd
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.
Official title: Multicenter, Randomized, Double-blind, Placebo-Controlled Phase IIIa Clinical Trial on the Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children Aged 6 to 71 Months.
Key Details
Gender
All
Age Range
6 Months - 71 Months
Study Type
INTERVENTIONAL
Enrollment
6000
Start Date
2026-05
Completion Date
2028-09
Last Updated
2026-05-28
Healthy Volunteers
Yes
Interventions
Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)
Two doses are administered with a one-month interval between each dose.
Placebo
Two doses are administered with a one-month interval between each dose.
Locations (5)
Anhui Provincial Center for Disease Control and Prevention
Hefei, Anhui, China
Fujian Provincial Center for Disease Control and Prevention
Fujian, China
Henan Provincial Center for Disease Control and Prevention
Henan, China
Hubei Provincial Center for Disease Control and Prevention
Hubei, China
Sichuan Provincial Center for Disease Control and Prevention
Sichuan, China