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NCT04067011 · ClinicalTrials.gov registry record · Phase 2
Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
A Phase 2 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
NCT04067011: Completed Phase 2 study, sponsored by Emergent BioSolutions.
NCT04067011 is a Phase 2 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 210 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04067011, a Phase 2 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
Study Summary
This study is designed to evaluate the pharmacokinetic (PK) profiles of ciprofloxacin or doxycycline when administered orally, prior to, and following, the intramuscular (IM) administration of a two-dose schedule of AV7909 administered two weeks apart.
Primary Outcome
Based on serum concentrations of ciprofloxacin on Day 8 (pre-AV7909 vaccination) and on Day 35 (post-AV7909 vaccination), steady state AUC0-12h and Cmax were derived, and geometric mean of ratio of AUC0-12h on Day35/Day 8 and geometric mean of ratio for Cmax on Day 35/Day8, and the corresponding 90% CI of the mean ratios were calculated.
Interventions
- BIOLOGICAL AV7909
- DRUG Ciprofloxacin 500Mg Tablet
- DRUG Doxycycline 100Mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2020-03-19 |
| Phase | Phase 2 |
What the finished NCT04067011 record still lists
NCT04067011 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 3 interventions - of which AV7909 is the first listed.
NCT04067011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04067011 about?
NCT04067011 is a clinical study titled "Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study". This study is designed to evaluate the pharmacokinetic (PK) profiles of ciprofloxacin or doxycycline when administered orally, prior to, and following, the intramuscular (IM) administration of a two-dose schedule of AV7909 administered two weeks apart.
What is the current status of trial NCT04067011?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2019-08-12. Estimated completion is 2020-03-19.
What interventions are being tested in trial NCT04067011?
The interventions under investigation include: AV7909 (BIOLOGICAL), Ciprofloxacin 500Mg Tablet (DRUG), Doxycycline 100Mg Tablet (DRUG).
Who is sponsoring clinical trial NCT04067011?
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 NCT04067011's enrollment target sits among peer trials
210 290th of 2000 higher than 1,707 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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