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Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)

NCT03729219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 749

Last updated 2019-11-08

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

E. coli ETVAX

Oral suspension Sterile water is added to dmLT . Vaccine is poured to the effervescent solution and needed amount of dmLT is added.

OTHER

Placebo

Oral suspension

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • United Medix Laboratories Ltd.

    collaborator UNKNOWN

  • Oy Medfiles Ltd

    collaborator INDUSTRY

  • University of Helsinki

    collaborator OTHER

  • University of Virginia

    collaborator OTHER

  • Scandinavian Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Anu Kantele · University of Helsinki, Dept. of Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2019-04-15
Completion
2019-04-15

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729219 on ClinicalTrials.gov