drugset / Trial / NCT00672035

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

NCT00672035 ↗

Phase 2 Completed 406 enrolled Intercell USA, Inc.
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2006-10
Primary completion
2006-12
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject heat-labile enterotoxin of E. coli (LT) Vaccine 7.5 ug Topical
Subject heat-labile enterotoxin of E. coli (LT) Vaccine 22.5 ug Topical
Subject heat-labile enterotoxin of E. coli (LT) Vaccine 37.5 ug Topical
Subject heat-labile enterotoxin of E. coli (LT) Vaccine 50 ug Topical

Indications