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.
Sinovac Biotech Co., Ltd
8,000 participants
Dec 13, 2024
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
Plain Language Summary
Simplified for easier understanding
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.
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Interventions
Two doses are administered with a one-month interval between each dose.
Two doses are administered with a one-month interval between each dose.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06734832