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NCT01311674 · ClinicalTrials.gov registry record · Phase 3
Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
A Phase 3 study, sponsored by Emergent BioSolutions.
- Terminated
- Registry status
- Phase 3
- Development phase
- 141
- Enrollment target
NCT01311674: Clinical Trial Phase 3 study, sponsored by Emergent BioSolutions.
NCT01311674 is a Phase 3 study that was terminated before completion, run by Emergent BioSolutions. The registered enrollment target is 141 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01311674, a Phase 3 study, was terminated before completion, sponsored by Emergent BioSolutions.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 141 participants
- Enrollment target
Study Summary
Hepatitis B Virus Antibody Booster Program
Primary Outcome
The primary endpoint for study HB-012 is area under the anti-HBs antibody concentration-time curve (AUC0-t) through Day 210. This endpoint was chosen because it allowed for the assessment of changes in anti HBs antibody concentration over time, and addressed one of the study objectives: to determine the effectiveness of Engerix-B booster vaccinations in the production of high anti-HBs titer plasma. By comparing AUC0-t between the two dosing schedules, the primary endpoint of AUC0-t also addresse
Interventions
- BIOLOGICAL hepatitis B vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-03-11 |
| Phase | Phase 3 |
Why NCT01311674 stopped before completion
NCT01311674 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which hepatitis B vaccine is the first listed.
NCT01311674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01311674 about?
NCT01311674 is a clinical study titled "Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)". Hepatitis B Virus Antibody Booster Program
What is the current status of trial NCT01311674?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2009-09. Estimated completion is 2011-03-11.
What interventions are being tested in trial NCT01311674?
The interventions under investigation include: hepatitis B vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01311674?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01311674's enrollment target sits among peer trials
141 1563rd of 2000 higher than 436 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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