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NCT01770743 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
A Phase 2 study of Anthrax, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
- 4
- Study locations
NCT01770743: Completed Phase 2 study of Anthrax, sponsored by Emergent BioSolutions.
NCT01770743 is a Phase 2 study of Anthrax that has completed, run by Emergent BioSolutions. The registered enrollment target is 168 participants, below the 750-participant average among 6 other Anthrax trials with a reported enrollment target (78% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01770743, a Phase 2 study of Anthrax, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.
Primary Outcome
Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold
Conditions Studied
Interventions
- BIOLOGICAL AV7909
- BIOLOGICAL BioThrax
Study Locations (4)
Florida
- Miami Research Associates - Miami
South Carolina
- Costal Carolina Research - Mt. Pleasant
Texas
- Central Texas Allergy and Asthma - New Braunfels
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01770743 record still lists
NCT01770743 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 750-participant average among 6 other Anthrax trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Anthrax appearing as the primary indexed condition, and to 2 interventions - of which AV7909 is the first listed.
NCT01770743 reports a single indexed study location in Florida, South Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT01770743 about?
NCT01770743 is a clinical study titled "A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels". The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.
What is the current status of trial NCT01770743?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2013-01. Estimated completion is 2014-12.
What conditions does trial NCT01770743 study?
This clinical trial studies the following conditions: Anthrax.
What interventions are being tested in trial NCT01770743?
The interventions under investigation include: AV7909 (BIOLOGICAL), BioThrax (BIOLOGICAL).
Who is sponsoring clinical trial NCT01770743?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01770743 being conducted?
This trial has 4 study locations across Florida, South Carolina, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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