drugset / Trial / NCT00672035
Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |