Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

Intercell

Status and phase

Completed

Phase 2

Conditions

Traveler's Diarrhea

Treatments

Biological: TD Vaccine System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01040325

ELT209

EudraCT Number: 2009-015603-10

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.

Enrollment

723 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.