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Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

NCT02117934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8374

Last updated 2019-03-20

Study results available
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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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

HEPLISAV

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

BIOLOGICAL

Engerix-B

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

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Robert Janssen, MD · Dynavax Technologies Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-10-31
Completion
2015-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02117934 on ClinicalTrials.gov