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NCT00511095 · ClinicalTrials.gov registry record · Phase 2
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
A Phase 2 study, sponsored by Dynavax Technologies Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 207
- Enrollment target
NCT00511095: Completed Phase 2 study, sponsored by Dynavax Technologies Corporation.
NCT00511095 is a Phase 2 study that has completed, run by Dynavax Technologies Corporation. The registered enrollment target is 207 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00511095, a Phase 2 study, has completed, sponsored by Dynavax Technologies Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 207 participants
- Enrollment target
Study Summary
The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.
Primary Outcome
Local and Systemic post-injection reactions.
Interventions
- BIOLOGICAL HEPLISAV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00511095 record still lists
NCT00511095 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher).
The record links to 0 conditions, and to 1 intervention - of which HEPLISAV is the first listed.
NCT00511095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00511095 about?
NCT00511095 is a clinical study titled "Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine". The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.
What is the current status of trial NCT00511095?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2007-06. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00511095?
The interventions under investigation include: HEPLISAV (BIOLOGICAL).
Who is sponsoring clinical trial NCT00511095?
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 NCT00511095's enrollment target sits among peer trials
207 297th of 2000 higher than 1,703 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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