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NCT01641991 · ClinicalTrials.gov registry record · Phase 4
Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 328
- Enrollment target
NCT01641991: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01641991 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 328 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01641991, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 328 participants
- Enrollment target
Study Summary
A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a major biothreat.
Primary Outcome
Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.
Interventions
- BIOLOGICAL BioThrax®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
What the finished NCT01641991 record still lists
NCT01641991 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which BioThrax® is the first listed.
NCT01641991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01641991 about?
NCT01641991 is a clinical study titled "Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule". A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a major biothreat.
What is the current status of trial NCT01641991?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 328 participants. The study started on 2012-07. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01641991?
The interventions under investigation include: BioThrax® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01641991?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01641991's enrollment target sits among peer trials
328 253rd of 2000 higher than 1,748 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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