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Completed Phase 3 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01005407

Public ClinicalTrials.gov record NCT01005407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 1:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT01005407
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
2,452 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
40 Years to 70 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2010 (Type not available)
Primary completion
Jan 2011 (Actual)
Completion
May 2011 (Actual)
Last update posted
Mar 20, 2019

2010 – 2011

United States locations

U.S. sites
29
U.S. states
17
U.S. cities
29
Facility City State ZIP Site status
Not listed Huntsville Alabama — —
Not listed San Diego California — —
Not listed Santa Ana California — —
Not listed Denver Colorado — —
Not listed Melbourne Florida — —
Not listed Pinellas Park Florida — —
Not listed Atlanta Georgia — —
Not listed Chicago Illinois — —
Not listed Peoria Illinois — —
Not listed South Bend Indiana — —
Not listed Rockville Maryland — —
Not listed Brooklyn Center Minnesota — —
Not listed Edina Minnesota — —
Not listed Kansas City Missouri — —
Not listed St Louis Missouri — —
Not listed Rochester New York — —
Not listed Cincinnati Ohio — —
Not listed Erie Pennsylvania — —
Not listed Grove City Pennsylvania — —
Not listed Jefferson Hills Pennsylvania — —
Not listed Pittsburgh Pennsylvania — —
Not listed Upper Saint Clair Pennsylvania — —
Not listed Anderson South Carolina — —
Not listed Greer South Carolina — —
Not listed Nashville Tennessee — —
Not listed Dallas Texas — —
Not listed Katy Texas — —
Not listed San Antonio Texas — —
Not listed Norfolk Virginia — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01005407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 20, 2019 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01005407 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →