Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

This is an interventional prevention trial for Traveler's Diarrhea Read More

Inclusion Criteria:

• 18-64 years of age at date of first vaccination
• Good health as determined by medical history and physical inspection
• 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
• 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).
• Subject must be able to communicate in English

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 in 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 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 from two weeks prior to randomization through the surveillance phase of the study;
• An employee of Intercell (global) or an immediate family member.