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NCT00678652 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00678652: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT00678652 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00678652, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other genetically modified strains as a potentially globally effective vaccine against group B meningococcus.
Primary Outcome
Measure the bactericidal absolute values per dose group after vaccine injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.
Interventions
- BIOLOGICAL 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
- BIOLOGICAL 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
- BIOLOGICAL 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
- BIOLOGICAL 75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00678652 record still lists
NCT00678652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine is the first listed.
NCT00678652 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00678652 about?
NCT00678652 is a clinical study titled "Phase 1 Safety and Immunogenicity of Meningococcal Vaccine". The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other genetically modified strains as ...
What is the current status of trial NCT00678652?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2008-04. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00678652?
The interventions under investigation include: 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine (BIOLOGICAL), 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine (BIOLOGICAL), 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine (BIOLOGICAL), 75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00678652?
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 NCT00678652's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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