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A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

NCT02417597 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-05-18

No results posted yet for this study

Summary

This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.

Conditions

  • Hepatitis E

Interventions

BIOLOGICAL

Recombinant Hepatitis E Vaccine (Escherichia Coli)

Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.

Sponsors & Collaborators

  • Xiamen University

    collaborator OTHER

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

    collaborator INDUSTRY

  • Xiamen Innovax Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhiping Chen · Zhejiang Provincial Center for Disease Control and Prevention

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

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 NCT02417597 on ClinicalTrials.gov