Phase 2b, Two-part, Open-label, Uncontrolled Study to Evaluate Safety, Tolerability, and Immunogenicity of a Single 40microg Dose of Recombinant Botulinum Vaccine A/B (rBV A/B) for the Production of BabyBIG in Plasma Donors Previously Immunized With Pentavalent Botulinum Toxoid for Occupational Protection

Trial Profile

Phase 2b, Two-part, Open-label, Uncontrolled Study to Evaluate Safety, Tolerability, and Immunogenicity of a Single 40microg Dose of Recombinant Botulinum Vaccine A/B (rBV A/B) for the Production of BabyBIG in Plasma Donors Previously Immunized With Pentavalent Botulinum Toxoid for Occupational Protection

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Feb 2018

At a glance

  • Drugs Botulism vaccine (Primary)
  • Indications Botulism
  • Focus Pharmacodynamics
  • Most Recent Events

    • 20 Feb 2018 Primary endpoint (Four-Fold Increase in Neutralizing Antibody Concentration (NAC)) has been met, according to the results published in the Vaccine
    • 20 Feb 2018 Results published in the Vaccine
    • 28 Jan 2016 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.
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