Traveler's Diarrhea
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.
Interventions
BIOLOGICALTD Vaccine System
TD Vaccine System containing heat labile enterotoxin of E. coli (LT)
Sponsors
Intercell USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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 and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study * Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 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 in 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 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 from two weeks prior to randomization through the surveillance phase of the study; * An employee of Intercell (global) or an immediate family member.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of cases with vaccine preventable outcome | within 17 days after arrival in destination country |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of moderate/severe diarrhea | within 17 days after arrival in destination country |
Countries
Germany, India, United Kingdom
Outcome results
None listed