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NCT02067676 · ClinicalTrials.gov registry record · Phase 1
Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02067676: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT02067676 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02067676, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety of increasing doses of a potential vaccine against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This study will also assess immune responses induced by the vaccine.
Primary Outcome
Vaccine safety will be assessed by evaluating post-vaccination local and systemic reactions through targeted physical exams, symptom surveys, and other adverse event (AE) monitoring. All subjects will be observed in the clinic for at least 30 minutes after receipt of the investigational product. Approximately 48 hours after vaccination, subjects will return to the Clinical Trials Center for observation and reporting of any local and/or systemic AEs. Seven days after vaccine administration, subje
Interventions
- BIOLOGICAL Capsule-Conjugate Campylobacter Vaccine (CJCV1)
- DRUG Alhydrogel®, aluminum hydroxide adjuvant (alum)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-04-21 |
| Est. Completion | 2016-01-22 |
| Phase | Phase 1 |
What the finished NCT02067676 record still lists
NCT02067676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Capsule-Conjugate Campylobacter Vaccine (CJCV1) is the first listed.
NCT02067676 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02067676 about?
NCT02067676 is a clinical study titled "Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea". The purpose of this study is to assess the safety of increasing doses of a potential vaccine against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This study will also assess immune responses induced by the vaccine.
What is the current status of trial NCT02067676?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2014-04-21. Estimated completion is 2016-01-22.
What interventions are being tested in trial NCT02067676?
The interventions under investigation include: Capsule-Conjugate Campylobacter Vaccine (CJCV1) (BIOLOGICAL), Alhydrogel®, aluminum hydroxide adjuvant (alum) (DRUG).
Who is sponsoring clinical trial NCT02067676?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02067676's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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