Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
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.
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
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
- Jan 31, 2010
- Primary completion
- Dec 31, 2010
- Completion
- Apr 30, 2011
- Last update posted
- Mar 19, 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 19, 2019 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01005407 live on ClinicalTrials.gov.