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

NCT06063057 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 744

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

  • Hand, Foot and Mouth Disease
  • Herpangina

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)

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zheng Yan · Yunnan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2025-12-19
Completion
2026-03-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06063057 on ClinicalTrials.gov