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:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT01003093
Eligibility Criteria:
Inclusion Criteria:
* Male
* Healthy based on medical examination/history at the inclusion
* Age between 18 and 55 years
* Signed informed consent
* Prepared to grant authorized persons access to the medical records
* The volunteer is likely to comply with instructions
Exclusion Criteria:
* Known exposure to TB before (or expected during) the trial
* Prior BCG vaccination
* Granulomatous disease (by chest X-ray, autoimmune screen)
* Vaccinated with live vaccine 3 months before first vaccination
* Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
* HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)
* Participation in other clinical trials
* Positive Mantoux or QuantiFERON-TB Gold
* Known hypersensitivity to any of the vaccine components
* Laboratory parameters outside of normal ranges considered clinically relevant
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01003093
Study Brief:
Protocol Section:
NCT01003093