drugset / Trial / NCT01940315

Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B

NCT01940315 ↗

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

EvaluationDrugModalityDoseRoute
Comparator rBV A/B Vaccine 40 ug Intramuscular
Comparator rBV A/B Vaccine 0.5 ml Intramuscular

Indications