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NCT01263691 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
NCT01263691: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT01263691 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01263691, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
Study Summary
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
Primary Outcome
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and red
Interventions
- BIOLOGICAL BioThrax
- BIOLOGICAL AV7909 Formulation 1
- BIOLOGICAL AV7909 Formulation 2
- BIOLOGICAL AV7909 Formulation 3
- BIOLOGICAL AV7909 Formulation 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01263691 record still lists
NCT01263691 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 5 interventions - of which BioThrax is the first listed.
NCT01263691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01263691 about?
NCT01263691 is a clinical study titled "Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults". The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and ...
What is the current status of trial NCT01263691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2010-12. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01263691?
The interventions under investigation include: BioThrax (BIOLOGICAL), AV7909 Formulation 1 (BIOLOGICAL), AV7909 Formulation 2 (BIOLOGICAL), AV7909 Formulation 3 (BIOLOGICAL), AV7909 Formulation 4 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01263691?
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 NCT01263691's enrollment target sits among peer trials
105 533rd of 2000 higher than 1,465 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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