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Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial
Sponsor: Sinovac Biotech Co., Ltd
Summary
The Phase I clinical trial is divided into two parts. The first part uses an open-label design, while the second part uses a randomized, double-blind, and controlled design. The goal of this clinical trial is to evaluate the tolerability and safety of a bivalent (EV71/CA16, Enterovirus 71/Coxsackievirus A16) inactivated enterovirus vaccine (Vero cell) developed by Sinovac. The vaccine will be administered to healthy adults, children aged 6 to 12 years, and children aged 6 to 71 months. The Phase II clinical trial will also use a randomized, double-blind, and controlled design to evaluate the safety and immunogenicity of the same bivalent inactivated enterovirus vaccine (Vero cell) developed by Sinovac. This trial will involve healthy children aged 6 to 71 months.
Official title: Inactivated Bivalent Enterovirus Vaccine Phase I/II Clinical Trial: Open-Label Observation in Healthy Adults and Children, and Randomized, Double-Blind, Controlled Clinical Trial in Children
Key Details
Gender
All
Age Range
6 Months - 59 Years
Study Type
INTERVENTIONAL
Enrollment
744
Start Date
2023-09-20
Completion Date
2026-03-10
Last Updated
2026-01-16
Healthy Volunteers
Yes
Conditions
Interventions
low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 480 U-CA16 600 SU/0.5 ml
medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 960 U-CA16 600 SU/0.5 ml
high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 1920U-CA16 1200SU/0.5ml
Enterovirus type EV71 vaccine (Vero cell), Inactivated
Enterovirus type EV71 vaccine (Vero cell), Inactivated (Sinovac)
Locations (1)
Dayao County Center for Disease Control and Prevention
Chuxiong, Yunnan, China