Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Condition(s) studied
Investigational drug(s) / intervention(s)
Tetravalent Inactivated Enterovirus Vaccine (Vero Cell): Two doses are administered with a one-month interval between each dose.
Placebo: Two doses are administered with a one-month interval between each dose.
Study summary
This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months.
Participants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.
Eligibility
Primary outcome measure(s)
- Evaluate the protective efficacy of the investigational vaccine against HFMD caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo. — From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months starting from Day 15 after full-course vaccination during the primary protective efficacy analysis stage. - Evaluate the protective efficacy of the investigational vaccine against HFMD caused by CA6 infection compared to placebo. — From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)From day 15 after the full-course vaccination to data cutoff date of primary analysis
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by CA6 in children aged 6 to 71 months starting from Day 15 after full-course vaccination during the primary protective efficacy analysis stage. - Evaluate the protective efficacy of the investigational vaccine against HFMD caused by CA16 infection compared to placebo. — From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by CA16 in children aged 6 to 71 months starting from Day 15 after full-course immunization during the primary protective efficacy analysis stage.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Provincial Center for Disease Control and Prevention | Hefei | Anhui | |
| Fujian Provincial Center for Disease Control and Prevention | Fujian | China | |
| Henan Provincial Center for Disease Control and Prevention | Henan | China | |
| Hubei Provincial Center for Disease Control and Prevention | Hubei | China | |
| Sichuan Provincial Center for Disease Control and Prevention | Sichuan | China |
More Sinovac Biotech Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07611513 on ClinicalTrials.gov ↗ ← All trials in China