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Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine

NCT04612634 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2021-02-26

No results posted yet for this study

Summary

Subjects will be recruited and divided into 3 groups:

1. Hepatitis A（Live）Vaccine，Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd
2. Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd., and
3. Hepatitis A（Live）Vaccine，Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences.

After immunization, the immunogenicity and safety of three different manufacturers will be compared and the data will be analyzed.

Conditions

  • Vaccination

Interventions

BIOLOGICAL

Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun

Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose

BIOLOGICAL

Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang

Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.

BIOLOGICAL

Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS

Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml per dose.

Sponsors & Collaborators

  • Changchun Institute of Biological Products Co., Ltd.

    collaborator INDUSTRY

  • Shaanxi Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Mianxian Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Yangxian Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Peking University

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Shaobai Zhang · Shaanxi Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2021-01-13
Completion
2021-07-31

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 NCT04612634 on ClinicalTrials.gov