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A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine

NCT02692170 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-11-18

No results posted yet for this study

Summary

A single center, randomized, double blinded phase I/IIa exploratory study to evaluate reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in human adult

Conditions

  • Healthy

Interventions

BIOLOGICAL

CVI-HBV-001

Investigational Product

BIOLOGICAL

Conventional Hepatitis B vaccine (20 μg)

Investigational Product

Sponsors & Collaborators

  • CHA Vaccine Institute Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Seong Gyu Hwang, M.D., Ph.D. · Bundang CHA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-07
Primary Completion
2015-05-28
Completion
2015-05-28

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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 NCT02692170 on ClinicalTrials.gov