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NCT01005407 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
A Phase 3 study, sponsored by Dynavax Technologies Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,452
- Enrollment target
NCT01005407: Completed Phase 3 study, sponsored by Dynavax Technologies Corporation.
NCT01005407 is a Phase 3 study that has completed, run by Dynavax Technologies Corporation. The registered enrollment target is 2,452 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (218% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01005407, a Phase 3 study, has completed, sponsored by Dynavax Technologies Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,452 participants
- Enrollment target
Study 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
Primary Outcome
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®
Interventions
- BIOLOGICAL Engerix-B
- BIOLOGICAL HEPLISAV and/or Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,452 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT01005407 record still lists
NCT01005407 is an interventional study that assigns participants to a tested intervention. Its 2,452 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (218% higher).
The record links to 0 conditions, and to 2 interventions - of which Engerix-B is the first listed.
NCT01005407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01005407 about?
NCT01005407 is a clinical study titled "Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine". 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
What is the current status of trial NCT01005407?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,452 participants. The study started on 2010-02. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01005407?
The interventions under investigation include: Engerix-B (BIOLOGICAL), HEPLISAV and/or Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT01005407?
This trial is sponsored by Dynavax Technologies Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01005407's enrollment target sits among peer trials
2,452 88th of 2000 higher than 1,913 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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