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NCT02339155 · ClinicalTrials.gov registry record · Phase 4
Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
A Phase 4 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 4
- Development phase
- 573
- Enrollment target
NCT02339155 is a Phase 4 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 573 participants.
The verdict
NCT02339155, a Phase 4 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 573 participants
- Enrollment target
Study Summary
This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.
Interventions
- DRUG Diphenhydramine
- BIOLOGICAL AVA
- BIOLOGICAL Raxibacumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 573 participants |
| Start Date | 2015-02-24 |
| Est. Completion | 2017-06-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02339155
The ClinicalTrials.gov registry entry for NCT02339155 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 573 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 3 interventions - of which Diphenhydramine is the first listed.
NCT02339155 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02339155 about?
NCT02339155 is a clinical study titled "Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed". This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogen...
What is the current status of trial NCT02339155?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 573 participants. The study started on 2015-02-24. Estimated completion is 2017-06-06.
What interventions are being tested in trial NCT02339155?
The interventions under investigation include: Diphenhydramine (DRUG), AVA (BIOLOGICAL), Raxibacumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02339155?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
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