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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 is a Phase 1 study that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 44 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00098098
The ClinicalTrials.gov registry entry for NCT00098098 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DynPort Vaccine Company LLC, A GDIT Company, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rBV A/B is the first listed.
NCT00098098 reports 0 study locations.
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.
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