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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT04475302
Eligibility Criteria:
Inclusion Criteria:
* Adults 60 years of age or older (\<100 years) with general good health, as confirmed by history and physical examination.
* No known history of HIV or on immunosuppressive drugs for malignancy or transplant
* Provide a signed and dated informed consent form
Exclusion Criteria:
* Positive for SARS-Cov2 infection
* Known HIV or other immune-suppressive treatments for malignancy or transplant
* Recently diagnosed as TB or currently on anti-TB treatment or anti-psychiatric medications
* Has any BCG vaccine contraindication
* H/o of previous administration of experimental MTB vaccines within the past 6 months.
* Sick and moribund individuals with Karnofsky score \<50
* Elderly individuals with or without co-morbid conditions like Diabetes mellitus, or Hypertension or Hyperlipidemia will be considered for this study, if they are on regular treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT04475302
Study Brief:
Protocol Section:
NCT04475302