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Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00993681
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : March 14, 2012
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.

Tracking Information
First Submitted Date  ICMJE October 8, 2009
First Posted Date  ICMJE October 12, 2009
Last Update Posted Date March 14, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
Incidence of cases with vaccine preventable outcome [ Time Frame: Day 17 (17 days after arrival in destination country) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
  • The incidence of moderate/severe diarrhea [ Time Frame: Day 17 (17 days after arrival in destination country) ]
  • Total unformed stool frequency from diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ]
  • Total duration of diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
Official Title  ICMJE A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Travelers' Diarrhea
Intervention  ICMJE
  • Biological: TD Vaccine System
    heat labile enterotoxin of E. coli (LT)
  • Biological: TD Vaccine System
    placebo
Study Arms  ICMJE
  • 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
Publications * Behrens RH, Cramer JP, Jelinek T, Shaw H, von Sonnenburg F, Wilbraham D, Weinke T, Bell DJ, Asturias E, Pauwells HL, Maxwell R, Paredes-Paredes M, Glenn GM, Dewasthaly S, Stablein DM, Jiang ZD, DuPont HL. Efficacy and safety of a patch vaccine containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase 3, randomised, double-blind, placebo-controlled field trial in travellers from Europe to Mexico and Guatemala. Lancet Infect Dis. 2014 Mar;14(3):197-204. doi: 10.1016/S1473-3099(13)70297-4. Epub 2013 Nov 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2012)
2036
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2009)
1800
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Guatemala,   Mexico,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00993681
Other Study ID Numbers  ICMJE ELT301
EudraCT Number: 2008-008726-75
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intercell USA, Inc.
Study Sponsor  ICMJE Intercell USA, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Herbert L Dupont, MD Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston
PRS Account Intercell USA, Inc.
Verification Date March 2012

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