Condition: Hand, Foot, and Mouth Disease（HFMD) · Sponsor: Sinovac Biotech Co., Ltd
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.
This description comes directly from the study's public registry record.
Liu Xiaoqiang, Dr. · 98-15911568282 · lxq7611@126.com
Always discuss trial participation with your own doctor first.
| Anhui Provincial Center for Disease Control and Prevention | Hefei, Anhui, China | Recruiting |
| Fujian Provincial Center for Disease Control and Prevention | Fujian, China | Recruiting |
| Guangdong Provincial Center for Disease Control and Prevention | Guangdong, China | Recruiting |
| Hubei Provincial Center for Disease Control and Prevention | Hubei, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06734832