At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-controlled Phase II b(OEV 123) Study to Evaluate Safety, Immunogenicity, Diagnostic Methodology, and Estimate Vaccine Efficacy of an Oral Enterotoxigenic Escherichia Coli(ETEC) Vaccine(ETVAX) for Prevention of Clinically Significant ETEC Diarrhea in Healthy Adult Travelers Visiting West Africa
In Brief
A Phase 2 clinical trial evaluating E. coli ETVAX and Placebo for Diarrhea. Completed, enrolled 749 participants across 1 site.
Detailed Summary
This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX. Participants will travel to Grand Popo, Africa for 12 days. Prior travelling participants will be vaccinated with two doses of vaccine or placebo. Vaccine Preventable Outcome will be identified and then characterized as to incidence, duration, severity and frequency of Moderate or Severe Travellers diarrhea. Health related information and assessments will be recorded during the travel.
Study Details
Timeline
Interventions
Oral suspension Sterile water is added to dmLT . Vaccine is poured to the effervescent solution and needed amount of dmLT is added.
Oral suspension