A randomized, double-blind, placebo-controlled dose escalation inpatient phase I study to determine the safety and immunogenicity of a single oral dose of a combined live, attenuated, enterotoxigenic Escherichia coli-cholera (ETEC)-cholera vaccine (Peru-15-pCTB) in healthy adult subjects.

Trial Profile

A randomized, double-blind, placebo-controlled dose escalation inpatient phase I study to determine the safety and immunogenicity of a single oral dose of a combined live, attenuated, enterotoxigenic Escherichia coli-cholera (ETEC)-cholera vaccine (Peru-15-pCTB) in healthy adult subjects.

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Oct 2016

At a glance

  • Drugs Cholera vaccine live attenuated (Primary) ; Ciprofloxacin
  • Indications Enterotoxigenic Escherichia coli infections; Traveller's diarrhoea
  • Focus Adverse reactions; First in man
  • Most Recent Events

    • 21 Jan 2011 Actual end date (Dec 2010) added as reported by ClinicalTrials.gov.
    • 21 Jan 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 24 Jun 2010 Status changed from recruiting to active, no longer recruiting Actual patient number (21) added as reported by ClinicalTrials.gov.
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