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Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

NCT00993681 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2036

Last updated 2012-03-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.

Conditions

  • Travelers' Diarrhea

Interventions

BIOLOGICAL

TD Vaccine System

heat labile enterotoxin of E. coli (LT)

BIOLOGICAL

TD Vaccine System

placebo

Sponsors & Collaborators

  • Intercell USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Herbert L Dupont, MD · Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-11-30
Completion
2011-04-30

Countries

  • Germany
  • Guatemala
  • Mexico
  • United Kingdom

Study Locations

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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 NCT00993681 on ClinicalTrials.gov