MedTrace Logo

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

NCT01940315 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-12-04

No results posted yet for this study

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.

Conditions

  • Botulism

Interventions

BIOLOGICAL

rBV A/B

0.5 mL dose of rBV A/B (40 µg) given at Days 0, 28 ± 5 days, and 182 ± 9 days

BIOLOGICAL

Placebo (USP sterile saline for injection)

0.5 mL dose of Placebo will be given at Days 0, 28 ± 5 days, and 182 ± 9 days

Sponsors & Collaborators

  • DynPort Vaccine Company LLC, A GDIT Company

    lead INDUSTRY

Principal Investigators

  • George A Saviolakis, M.D., Ph.D. · DynPort Vaccine Company LLC, A GDIT Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-03-31
Completion
2019-09-30
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940315 on ClinicalTrials.gov