drugset / Trial / NCT01940315
Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.
Timeline
- Start
- 2017-10
- Primary completion
- 2019-03
- Completion
- 2019-09
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision due to product manufacturing and redesign of clinical trial.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | rBV A/B | Vaccine | 40 ug | Intramuscular |
| Comparator | rBV A/B | Vaccine | 0.5 ml | Intramuscular |