Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT00516659
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult men and women 18-64 years of age inclusive at screening
* Signed Informed Consent form
* Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days)
* If female who is not post-menopausal or surgically sterile, negative pregnancy test (within 24 hours prior to vaccination) and agreement to employ an effective form of birth control or practice abstinence through the end of the study.
Exclusion Criteria:
* Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection
* Received investigational product from 30 days before date of first vaccination or during the entire study period
* Ever received LT, ETEC, or cholera vaccine
* History of traveler's diarrhea within the previous year
* Travel to a developing country within the last year
* Women who are pregnant or breastfeeding
* History of achlorhydria
* Evidence of immunosuppression, including concomitant immunosuppressive therapy; fever \> 99.5°F (37.5°C) on day of vaccination
* Current problems with alcohol or substance abuse
* An employee of the study clinic
* Sensitivity or allergy to any of the vaccine components
* History of significant blood loss, blood product donation, or blood product recipient in the previous 60 days
* Planned use of Imodium or antibiotics for self treatment of diarrhea during the study period
* Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and
* Medical history of acute or chronic GI illness or major GI surgery.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00516659
Study Brief:
Protocol Section:
NCT00516659