RecruitingPhase 3NCT06734832

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

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.


Sponsor

Sinovac Biotech Co., Ltd

Enrollment

8,000 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 MonthsMax Age: 71 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Enterovirus Type 71 Vaccine (Vero Cell), Inactivated and a biological treatment called bivalent enterovirus vaccine (Vero cell), inactivated for people with hand, foot, and mouth disease(hfmd). The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALbivalent enterovirus vaccine (Vero cell), inactivated

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

BIOLOGICALEnterovirus 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06734832