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NCT03160339 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047
A Phase 1 study, sponsored by Emergent BioSolutions.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT03160339: Clinical Trial Phase 1 study, sponsored by Emergent BioSolutions.
NCT03160339 is a Phase 1 study that was terminated before completion, run by Emergent BioSolutions. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03160339, a Phase 1 study, was terminated before completion, sponsored by Emergent BioSolutions.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine \[A549 Cells\], Live, Oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immunogenicity of PXVX0047.
Primary Outcome
Incidence of severity of solicited adverse events include abdominal pain, nausea, vomiting, diarrhea, cough, nasal congestion, dyspnea, sore throat, headache, fever fatigue chills myalgia, arthralgia
Interventions
- BIOLOGICAL PXVX0047 Vaccine
- BIOLOGICAL Teva Ad4/Ad7 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2017-11-27 |
| Phase | Phase 1 |
Why NCT03160339 stopped before completion
NCT03160339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which PXVX0047 Vaccine is the first listed.
NCT03160339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03160339 about?
NCT03160339 is a clinical study titled "A Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047". PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine \[A549 Cells\], Live, Oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immun...
What is the current status of trial NCT03160339?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2017-05-01. Estimated completion is 2017-11-27.
What interventions are being tested in trial NCT03160339?
The interventions under investigation include: PXVX0047 Vaccine (BIOLOGICAL), Teva Ad4/Ad7 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03160339?
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 NCT03160339's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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