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Clinical Trial of Recombinant Hepatitis E Vaccine

NCT01014845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112604

Last updated 2020-07-13

No results posted yet for this study

Summary

The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine.

The secondary purpose of this study is to to evaluate the safety and immunogenicity and immunopersistence of the study vaccine.

The initial study is planed to be ended on month 19 and the results were analysed and used for registration purpose. The extended study will be continued to assess the long-term efficacy, immunogenicity and safety.

Conditions

  • Hepatitis E

Interventions

BIOLOGICAL

hepatitis E vaccine

Intramuscularly given at 0, 1, 6m for three doses.

BIOLOGICAL

Hepatitis B vaccine

Intramuscularly given at 0, 1, 6m for three doses.

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

    collaborator INDUSTRY

  • National Institute of Diagnostics and Vaccine Development in infectious disease

    collaborator UNKNOWN

  • Jiangsu Provincial Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Xiamen University

    lead OTHER

Principal Investigators

  • Jun Zhang, M.D. · National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University

  • Feng-Cai Zhu, M.D. · Jiangsu Provincial Center for Disease Control and Prevention, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2017-10-31
Completion
2017-10-31

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 NCT01014845 on ClinicalTrials.gov