Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study

Traveler's Diarrhea Clinical Trial

Official title: Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging Study to Assess the Immunogenicity and Safety of LT Application in Healthy Adults

Status Completed

Clinical Trial Summary

The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses.

The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, dose ranging, multicenter study. Subjects will be assigned to one of ten treatment groups and vaccinated according to the study group designation. Treatments will remain the same for first and second vaccinations (alternating left and right sides). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Traveler's Diarrhea

• NCT number: NCT00672035
• Study type: Interventional
• Source: Intercell USA, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Completion date: July 2008