drugset / Trial / NCT02692170

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

NCT02692170 ↗

Phase 1/2 Completed 75 enrolled CHA Vaccine Institute Co., Ltd.
RandomizedParallel-groupDouble-blindPrevention

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject CVI-HBV-001 Vaccine 5 ug Intramuscular
Subject CVI-HBV-001 Vaccine 10 ug Intramuscular
Subject CVI-HBV-001 Vaccine 20 ug Intramuscular
Subject CVI-HBV-001 Vaccine 40 ug Intramuscular
Comparator Conventional Hepatitis B vaccine Vaccine 20 ug Intramuscular

Indications

No indication recorded.