Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

Exclusion Criteria

• •Abnormalities as determined by the Investigator/clinician during physical inspection
• •Participated in research involving investigational product within 30 days before planned date of first vaccination
• •Ever received LT, ETEC, or cholera vaccine
• •History of diarrhea while traveling to a developing country within the last year
• •Women who are pregnant or breastfeeding
• •Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease
• •History of Irritable Bowel Syndrome
• •Seizure disorder within the last year
• •Current use of immunosuppressive therapy (excluding inhaled steroids) or current immunodeficiency
• •Known or suspected alcohol abuse or illicit drug use within the last year
• •Medical history of HIV, HBV, or HCV
• •An employee of a study site
• •Known allergies to any component of the vaccine, including adhesives
• •Planned use of antibiotics with known activity against gram negative facultative anaerobes
• •Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar during the surveillance phase of the study
• •An employee of Intercell (global) or an immediate family member