ELT209: a Phase Two, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers Diarrhea Vaccine System in Travelers to Asia

INTERVENTION: Intervention1: Heat‐Labile Enterotoxin Of Escherichia Coli: 37.5μg LT, two vaccinations (skin preparation and patch application) performed 14 days apart. Vaccinations will be administered by a clinician to alternating deltoids. Patches will be worn for six hours prior to removal by the subject. Control Intervention1: Placebo: The treatment regimen for the TD Vaccine System is two vaccinations (skin preparation and patch application) performed 14 days apart. Vaccinations will be administered by a clinician to alternating deltoids. Patches will be worn for six hours prior to removal by the subject. CONDITION: Travelers Diarrhea PRIMARY OUTCOME: The incidence of cases of moderate/severe diarrheal cases during the surveillance period in which LT, LT/ST or ST toxins (ETEC) are detected.‐‐‐‐‐‐Timepoint: 9 Months SECONDARY OUTCOME: The incidence, total stool frequency, and total duration of diarrheal episodes experienced during the surveillance period.‐‐‐‐‐‐Timepoint: 9 Months INCLUSION CRITERIA: "A subject may be included in the study if he/she meets all of the following INCLUSION CRITERIA: 1) 18‐64 years of age at date of first vaccination; 2) Good health as determined by medical history and physical inspection; 3) Females of child‐bearing potential must have a negative pregnancy test prior to first and second vaccination in the Country of Origin; females of child‐bearing potential must agree not to become pregnant throughout the duration of study; 4) Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion). 5) Subject must be able to communicate in English"