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Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

NCT01067781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-02-10

Study results available
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Summary

The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing

Conditions

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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-09-30
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01067781 on ClinicalTrials.gov