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NCT01491607 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
A Phase 3 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT01491607: Completed Phase 3 study, sponsored by Emergent BioSolutions.
NCT01491607 is a Phase 3 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01491607, a Phase 3 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study Summary
The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax. This study will be conducted in the United States (U.S.), in 200 healthy male and female volunteer subjects ages 18 to 65 years. The duration of study participation for each individual subject will be approximately 128 days (4.25 months), including a screening period of approximately 28 days followed by 100 days on study.
Primary Outcome
Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Interventions
- BIOLOGICAL BioThrax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT01491607 record still lists
NCT01491607 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (74% lower).
The record links to 0 conditions, and to 1 intervention - of which BioThrax is the first listed.
NCT01491607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01491607 about?
NCT01491607 is a clinical study titled "Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults". The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax. This study will be conducted ...
What is the current status of trial NCT01491607?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2011-11. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01491607?
The interventions under investigation include: BioThrax (BIOLOGICAL).
Who is sponsoring clinical trial NCT01491607?
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 NCT01491607's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 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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