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Report for Clinical Trial NCT00672035
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
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.
NCT00672035 Traveler's Diarrhea
1 Interventions
Name: Biological: heat-labile enterotoxin of E. coli (LT)
Description: LT patch applied on either the deltoid or the lower back.
Type: Biological
Group Labels: 10 1 10 2 3 4 5 6 7 8 9
Primary Outcomes
Measure: To evaluate the immunogenicity of LT application at different doses Time: 6 months
Secondary Outcomes
Measure: To evaluate the safety of LT application at different doses Time: 6 months
Measure: To evaluate the safety of the skin preparation system Time: 6 months
Measure: To compare patch performance (safety and immunogenicity) on different anatomical parts of the body Time: 6 months
Purpose: Prevention
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
- Ever received investigational enterotoxigenic E. coli, LT, or LT(R192G) or NasalFlu,
Berna Biotech, Ltd.
- Ever received cholera toxin or vaccine (e.g. --- R192G ---