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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT00672035
Eligibility Criteria:
Subjects must meet all of the following criteria to be eligible to participate in the study:
Inclusion Criteria:
* Healthy adult males or females 18 to 40 years of age with signed informed consent.
* Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours prior to each vaccination with understanding (through informed consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study.
* Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom, diaphragm with spermicide), and IUD.
Subjects meeting any of the following criteria are not eligible for participation in the study:
Exclusion Criteria:
* Laboratory abnormalities.
* Abnormalities at physical examination
* Known allergies to any component of the vaccine.
* Known disturbance of coagulation.
* Known allergies to adhesives.
* Participated in unrelated research involving investigational product within 30 days before planned date of first vaccination.
* Ever received investigational enterotoxigenic E. coli, LT, or LT(R192G) or NasalFlu, Berna Biotech, Ltd.
* Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™).
* Medical history of acute or chronic skin disease at vaccination site(s).
* Active skin allergy.
* Recent or regular use of oral or injected steroid medications.
* Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination.
* Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, end-stage renal disease, as determined by the Investigator.
* Positive serology for HIV-1, HIV-2, HBsAg, or HCV.
* History of severe atopy. Signs or history of acute skin infection, sunburn or skin abnormalities on the vaccination area(s) including fungal infections, severe acne, history of keloid formation, or active contact dermatitis.
* Artificial tanning (UV radiation) over the duration of the study including the screening period.
* Hirsute (significant amount of hair) at vaccination area(s).
* Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatological monitoring of the vaccination site(s).
* Fever equal to or greater than 38.0°C (≥100.4°F) at the time of planned vaccination.
* Suspicion of or recent history of alcohol or substance abuse.
* Donated blood or blood products such as plasma within the past 30 days.
* Women who are pregnant or breastfeeding.
* Employee of the investigational site.
* Medical history of achlorhydria.
* History of abdominal surgery (excluding C-section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal illness.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00672035
Study Brief:
Protocol Section:
NCT00672035