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Safety, Reactogenicity, Tolerability, Immunogenicity and Efficacy of Live Attenuated ETEC ACE527 Vaccine Administered Alone or With a Double Mutant E. Coli Heat Labile Toxin (dmLT) in Healthy Adult Volunteers

Trial Profile

Safety, Reactogenicity, Tolerability, Immunogenicity and Efficacy of Live Attenuated ETEC ACE527 Vaccine Administered Alone or With a Double Mutant E. Coli Heat Labile Toxin (dmLT) in Healthy Adult Volunteers

Completed
Phase of Trial: Phase I/II

Latest Information Update: 20 Feb 2019

At a glance

  • Drugs ACE 527 (Primary) ; Double mutant heat-labile toxin (Primary)
  • Indications Enterotoxigenic Escherichia coli infections
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 20 Feb 2019 Primary endpoint (Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain) has been met, according to results published in the Vaccine.
    • 20 Feb 2019 Safety and efficacy results published in the Vaccine.
    • 20 Mar 2013 official title amended, primary endpoint added and planned number of patients changed from 60 to 120 as reported by ClinicalTrials.gov.
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