drugset
drugset / Trial / NCT01195246

Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis

NCT01195246 ↗

Phase 3 Completed 155 enrolled Dynavax Technologies Corporation
RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.

Timeline

Start
2010-12
Primary completion
2012-02
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Engerix-B Vaccine 2 ml Intramuscular
Comparator Fendrix Vaccine 0.5 ml Intramuscular
Subject HEPLISAV Vaccine 0.5 ml Intramuscular

Indications

end stage renal failure