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Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

NCT01040325 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 723

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 TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.

Conditions

  • Traveler's Diarrhea

Interventions

BIOLOGICAL

TD Vaccine System

TD Vaccine System containing heat labile enterotoxin of E. coli (LT)

BIOLOGICAL

TD Vaccine System

TD Vaccine System Containing Placebo Product

Sponsors & Collaborators

  • Intercell USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Steffen, MD · University of Zurich

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
2009-12-31
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • Germany
  • India
  • 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 NCT01040325 on ClinicalTrials.gov