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A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults

NCT02603055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-09-01

No results posted yet for this study

Summary

Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine.

This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.

Conditions

  • Hepatitis E

Interventions

BIOLOGICAL

30μg/0.5ml Hepatitis E vaccine

three doses, 30μg/0.5ml per dose

BIOLOGICAL

30μg/0.5ml Recombinant Hepatitis E vaccine

30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose

Sponsors & Collaborators

  • Changchun Institute of Biological Products Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-04-30
Completion
2016-08-31

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 NCT02603055 on ClinicalTrials.gov