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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02814708
Eligibility Criteria:
Inclusion Criteria:
* males or females aged 18-64 years
* signed informed consent
* physical exam: no abnormal findings unless considered irrelevant by the investigator
* uneventful medical history
* Females with childbearing potential: adequate contraception
Exclusion Criteria:
* females with childbearing potential: pregnancy, lactation or unreliable contraception
* positive HIV Ab and/or positive HCV Ab and/or positive HBsAG signs and symptoms of autoimmunity
* TSST-1 Ab titer \> 1:1000
* current or recent (\< 1 month) immunosuppressive therapy with corticosteroids or immunomodulators
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02814708
Study Brief:
Protocol Section:
NCT02814708