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NCT00098098 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults
A Phase 1 study, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT00098098: Completed Phase 1 study, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
NCT00098098 is a Phase 1 study that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00098098, a Phase 1 study, has completed, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level.
Interventions
- BIOLOGICAL rBV A/B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2004-08 |
| Est. Completion | 2005-08 |
| Phase | Phase 1 |
What the finished NCT00098098 record still lists
NCT00098098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which rBV A/B is the first listed.
NCT00098098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00098098 about?
NCT00098098 is a clinical study titled "Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults". The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulat...
What is the current status of trial NCT00098098?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2004-08. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00098098?
The interventions under investigation include: rBV A/B (BIOLOGICAL).
Who is sponsoring clinical trial NCT00098098?
This trial is sponsored by DynPort Vaccine Company LLC, A GDIT Company, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00098098's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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