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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT01920750
Eligibility Criteria:
Inclusion Criteria:
* Born in the United States (less chance of previous exposure to tuberculosis or leprosy)
* Healthy individuals who are free of any evidence of leprosy or tuberculosis by established clinical examinations
* Between the ages of 18 and 40 years old
* Females of child-bearing age (defined from the period of menarche to menopause, usually between the ages of 15 to 45), certified as not pregnant (as determined by a pregnancy test performed within 7 days prior to admission into the study)
* Agreement to participate in the study after verbal explanation by the physician and nurses and signing of an informed consent form.
* Weight greater than 100 lbs. (female) and.140 lbs. (male)
* No known hypersensitivities or allergies
* Negative tuberculin skin test (as determined by skin tests performed 3 weeks prior to study entry)
Exclusion Criteria:
* Pregnant or lactating females
* Oral corticosteroid treatment
* Chronic illness
* Immunosuppressive condition
* Tuberculosis
* Leprosy
* Age \<18 or \>40
* Weight \<100 lbs. (female) or \<140 lbs. (male)
* Positive tuberculin skin test
* Extensive travel (2-3 trips/year) in leprosy/tuberculosis endemic regions
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01920750
Study Brief:
Protocol Section:
NCT01920750