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Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

NCT01005407 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2452

Last updated 2019-03-20

Study results available
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Summary

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Conditions

  • Healthy

Interventions

BIOLOGICAL

HEPLISAV and/or Placebo

Intramuscular (IM) injections on Week 0 and 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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-01-31
Completion
2011-05-31
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT01005407 on ClinicalTrials.gov