Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System

Conditions
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Travelers' Diarrhea

Intervention / Treatment
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* Biological: TD Vaccine System
* Biological: TD Vaccine System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>900 subjects will receive a two vaccination regimen with an LT patch | Biological: TD Vaccine System<br>* heat labile enterotoxin of E. coli (LT)<br>|
| Placebo Comparator: 2<br>900 subjects will receive a two vaccination regimen with a placebo patch | Biological: TD Vaccine System<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cases with vaccine preventable outcome |  | Day 17 (17 days after arrival in destination country) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of moderate/severe diarrhea |  | Day 17 (17 days after arrival in destination country) | 
| Total unformed stool frequency from diarrheal episodes |  | Day 17 (17 days after arrival in destination country) | 
| Total duration of diarrheal episodes |  | Day 17 (17 days after arrival in destination country) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Travelers' Diarrhea