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RECRUITING
NCT06734832
PHASE3

Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)

Sponsor: Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

bivalent enterovirus vaccine (Vero cell), inactivated

Two doses are administered with a one-month interval between each dose.

BIOLOGICAL

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