NCT00672035

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Intercell USA, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Traveler's Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Biological: heat-labile enterotoxin of E. coli (LT)	LT patch applied on either the deltoid or the lower back.

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-12-01
• Completion: 2008-07-01
• First posted: 2008-05-06
• Last updated: 2012-03-14

Locations

5 sites across 1 country: United States