Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

I

Intercell USA, Inc.

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

Trial design

2,036 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
900 subjects will receive a two vaccination regimen with an LT patch
Treatment:
Biological: TD Vaccine System
2
Placebo Comparator group
Description:
900 subjects will receive a two vaccination regimen with a placebo patch
Treatment:
Biological: TD Vaccine System

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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