ETEC Logistics Trial (TREK)

Exclusion Criteria

• •Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection
• •Received investigational product from 30 days before date of first vaccination or during the entire study period
• •Ever received LT, ETEC, or cholera vaccine
• •History of traveler's diarrhea within the previous year
• •Travel to a developing country within the last year
• •Women who are pregnant or breastfeeding
• •History of achlorhydria
• •Evidence of immunosuppression, including concomitant immunosuppressive therapy; fever \> 99.5°F (37.5°C) on day of vaccination
• •Current problems with alcohol or substance abuse
• •An employee of the study clinic
• •Sensitivity or allergy to any of the vaccine components
• •History of significant blood loss, blood product donation, or blood product recipient in the previous 60 days
• •Planned use of Imodium or antibiotics for self treatment of diarrhea during the study period
• •Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and
• •Medical history of acute or chronic GI illness or major GI surgery.