Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)
Sponsor: Sinovac Biotech Co., Ltd
Summary
This multicenter, randomized, double-blind, controlled Phase III clinical trial aims to evaluate the efficacy, safety, and immunogenicity of the bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to 71 months. The main questions it aims to answer are: * The primary vaccine efficacy of the investigational vaccine against Hand, Foot, and Mouth Disease(HFMD) caused by CA16 infection compared to the control vaccine. * The neutralizing antibody levels against EV71 in the trial group are non-inferior to those in the control group after two doses of vaccination. Researchers will compare the bivalent enterovirus-inactivated vaccine (Vero cell) to the EV71-inactivated vaccine (Vero cell) to prevent HFMD and Herpangina(HA). Participants will be randomly assigned to the trial group and the control group in a 1:1 ratio to receive two doses of the investigational vaccine or the control EV71 vaccine, with a one-month interval between doses.
Official title: A Multicenter, Randomized, Double-blind, Controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of the Bivalent Enterovirus Inactivated Vaccine (Vero Cell) in Children Aged 6 to 71 Months.
Key Details
Gender
All
Age Range
6 Months - 71 Months
Study Type
INTERVENTIONAL
Enrollment
8000
Start Date
2024-12-13
Completion Date
2026-11-30
Last Updated
2025-01-01
Healthy Volunteers
Yes
Conditions
Interventions
bivalent enterovirus vaccine (Vero cell), inactivated
Two doses are administered with a one-month interval between each dose.
Enterovirus Type 71 Vaccine (Vero Cell), Inactivated
Two doses are administered with a one-month interval between each dose.
Locations (4)
Anhui Provincial Center for Disease Control and Prevention
Hefei, Anhui, China
Fujian Provincial Center for Disease Control and Prevention
Fujian, China
Guangdong Provincial Center for Disease Control and Prevention
Guangdong, China
Hubei Provincial Center for Disease Control and Prevention
Hubei, China