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

Healthy Clinical Trial

Official title:
A Single Center, Randomized, Double Blinded PhaseI/IIa Exploratory Study to Evaluate Reactogenicity, Safety, Immunogenicity and Dose Response of a New Hepatitis B Vaccine in Human Adult

Clinical Trial 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

Clinical Trial Description

- Objectives: To explore the most effective dose of the third generation Hepatitis B vaccine through the evaluation of reactogenicity, safety, and immunogenicity. - Subjects: Adults having anti-HBs antibody titers less than 10 mIU/mL after 3 previous injections of the conventional Hepatitis B vaccine. - Study hypothesis: The third generation Hepatitis B vaccine, containing preS antigens in addition to S antigen, has an ability to elicit faster protection and higher antibody titers than the second generation Hepatitis B vaccine in the subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02692170
Study type Interventional
Source CHA Vaccine Institute Co., Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 7, 2012
Completion date May 28, 2015
View Details
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