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

NCT02964910 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2019-07-25

Study results available
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Summary

This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.

Conditions

  • Hepatitis E

Interventions

BIOLOGICAL

Recombinant Hepatitis E Vaccine (Escherichia Coli)

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

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Aiqiang Xu · Shandong Provincial Center for Disease Control and Prevention

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-08-31
Completion
2017-12-31

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 NCT02964910 on ClinicalTrials.gov