drugset
drugset / Trial / NCT00435812

Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine

NCT00435812 ↗

Phase 3 Completed 2428 enrolled Dynavax Technologies Corporation
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.

Timeline

Start
2006-12
Primary completion
2008-02
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Engerix-B Vaccine 1 ml Intramuscular
Subject HEPLISAV Vaccine 0.5 ml Intramuscular

Indications

hepatitis B virus infection