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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 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 105 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01263691
The ClinicalTrials.gov registry entry for NCT01263691 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 105 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 5 interventions - of which BioThrax is the first listed.
NCT01263691 reports 0 study locations.
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.
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