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Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

NCT06564116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2024-08-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli) when administered in participants ages 16 years and above.

Conditions

  • Hepatitis E

Interventions

BIOLOGICAL

Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)

Participants would receive 3 doses of thiomersal-free hepatitis E vaccine intramuscularly at month 0, 1 and 6.

BIOLOGICAL

Recombinant Hepatitis E Vaccine (Escherichia Coli)

Participants would receive 3 doses of licensed hepatitis E vaccine intramuscularly at month 0, 1 and 6

Sponsors & Collaborators

  • Center for Disease Control and Prevention, Fujian

    collaborator OTHER

  • Xiamen Innovax Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Dongjuan Zhang · Center for Disease Control and Prevention, Fujian

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2024-03-28
Completion
2024-03-28

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 NCT06564116 on ClinicalTrials.gov