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ACTIVE NOT RECRUITING
NCT06063057
PHASE1/PHASE2

Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial

Sponsor: Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated

Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 1920U-CA16 1200SU/0.5ml

BIOLOGICAL

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