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.
Who can participate
Age range18 Years – 64 Years
SexALL
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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, HB…
What they're measuring
1
Incidence of cases with vaccine preventable outcome
Timeframe: Day 17 (17 days after arrival in destination country)