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NOT YET RECRUITING
NCT07326878
PHASE1

Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine

Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

This is a randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine in subjects ( aged 6 months to 59 years ).

Official title: A Single-center, Randomized, Double-blind, and Placebo Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine in People Aged 6 Months to 59 Years

Key Details

Gender

All

Age Range

6 Months - 59 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-12-30

Completion Date

2027-08-15

Last Updated

2026-01-08

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)

Low-dose vaccine,dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

BIOLOGICAL

Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)

Medium-dose vaccine,dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

BIOLOGICAL

High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)

High-dose vaccine,dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

BIOLOGICAL

Placebo

Placebo,dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

Locations (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China