A Phase 1/2b Randomized, Double-Blinded, Placebo-controlled Study to Assess the 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

A Phase 1/2b Randomized, Double-Blinded, Placebo-controlled Study to Assess the 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: 13 May 2014

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 Mar 2013 official title amended, primary endpoint added and planned number of patients changed from 60 to 120 as reported by ClinicalTrials.gov.
    • 20 Mar 2013 Planned End Date changed from 1 Mar 2013 to 1 Jun 2014 as reported by ClinicalTrials.gov.
    • 08 Jan 2013 New trial record
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