Status:
COMPLETED
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
Lead Sponsor:
Intercell USA, Inc.
Conditions:
Travelers' Diarrhea
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
2036 Patients enrolled
Trial Details
Trial ID
NCT00993681
Start Date
October 1 2009
End Date
April 1 2011
Last Update
March 14 2012
Active Locations (20)
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1
University Medical Centre Hamburg-Eppendorf
Hamburg, Hamburg, Germany, 20359
2
Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin
München, Munchen, Germany, 80802
3
Klinik for Gastroenterologie & Infektiologie
Potsdam, Potsdam, Germany, 14467
4
Berliner Centrum Reise & Tropenmedizin
Berlin, State of Berlin, Germany, 10117