Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00993681
First received: October 8, 2009
Last updated: March 13, 2012
Last verified: March 2012

October 8, 2009
March 13, 2012
October 2009
November 2010   (final data collection date for primary outcome measure)
Incidence of cases with vaccine preventable outcome [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00993681 on ClinicalTrials.gov Archive Site
  • The incidence of moderate/severe diarrhea [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
  • Total unformed stool frequency from diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
  • Total duration of diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Travelers' Diarrhea
  • Biological: TD Vaccine System
    heat labile enterotoxin of E. coli (LT)
  • Biological: TD Vaccine System
    placebo
  • Experimental: 1
    900 subjects will receive a two vaccination regimen with an LT patch
    Intervention: Biological: TD Vaccine System
  • Placebo Comparator: 2
    900 subjects will receive a two vaccination regimen with a placebo patch
    Intervention: Biological: TD Vaccine System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2036
April 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom,   Guatemala,   Mexico
 
NCT00993681
ELT301, EudraCT Number: 2008-008726-75
Yes
Intercell USA, Inc.
Intercell USA, Inc.
Not Provided
Principal Investigator: Herbert L Dupont, MD Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston
Intercell USA, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP