CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,374 enrolled
Drug / intervention
HEPLISAV +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02117934
NCT02117934Phase 3Completed
CompareCT.gov

A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Dynavax Technologies Corporation·interventional·Posted Apr 21, 2014·Updated Mar 20, 2019

In Brief

A Phase 3 clinical trial evaluating HEPLISAV and Engerix-B for Healthy. Completed, enrolled 8,374 participants across 40 sites.

Detailed Summary

The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 21, 2014
Enrollment StartApr 1, 2014
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.2 years ago

Interventions

HEPLISAVbiological

Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24

Engerix-Bbiological

Intramuscular injections at Week 0, Week 4, and Week 24