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

NCT00435812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2428

Last updated 2019-03-20

Study results available
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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®.

Conditions

Interventions

BIOLOGICAL

HEPLISAV and/or Placebo

Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24

BIOLOGICAL

Engerix-B

Intramuscular (IM) injections on Week 0, Week 4, and Week 24

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • J. Tyler Martin, Sr, MD · Dynavax Technologies Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-02-29
Completion
2008-03-31
FDA Drug
Yes

Countries

  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00435812 on ClinicalTrials.gov