Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

Intercell

Status and phase

Completed

Phase 3

Conditions

Travelers' Diarrhea

Treatments

Biological: TD Vaccine System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00993681

ELT301

EudraCT Number: 2008-008726-75

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.

Enrollment

2,036 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 vaccination in teh Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of the study
Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quezaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay 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 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