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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 is a Phase 3 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 200 participants.
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.
Interventions
- BIOLOGICAL BioThrax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01491607
The ClinicalTrials.gov registry entry for NCT01491607 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BioThrax is the first listed.
NCT01491607 reports 0 study locations.
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.
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