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

NCT07326878 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-01-08

No results posted yet for this study

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 ).

Conditions

  • Hand, Foot and Mouth Disease (HFMD)
  • HFMD
  • Hand, Foot and Mouth Disease

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

Sponsors & Collaborators

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Xian Yu · The Second Affiliated Hospital of Chongqing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2026-08-15
Completion
2027-08-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07326878 on ClinicalTrials.gov