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Traveler's Diarrhea (TD) Automated Process

NCT00751777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-01-29

Study results available
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Summary

To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.

Conditions

  • Prevention of Travelers' Diarrhea

Interventions

BIOLOGICAL

heat-labile enterotoxin of E. coli (LT)

Travelers' Diarrhea Vaccine System

BIOLOGICAL

Placebo

Travelers' Diarrhea Vaccine System

Sponsors & Collaborators

  • Intercell USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sheldon, MD · Miami Research Associates

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
2008-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00751777 on ClinicalTrials.gov