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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT01169935
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female volunteers age 18 to 65 years
* Previous vaccine for tuberculosis more than 5 years ago
Exclusion Criteria:
* pregnancy / breast feeding
* Contra-indication to MRI scanning
* Inability or refusal to give informed consent
* Renal failure (eGFR \<25mL/min) or hepatic dysfunction (Child's B or C)
* HIV/hepatitis B/hepatitis C/HTLV/syphilis
* Active malignant disease
* Anaemia
* Blood dyscrasia
* High risk of allergy to protamine sulphate (fish allergy, infertile men, vasectomy)
* Known history of tuberculosis infection.
* History of prolonged residence (\> 6 months) in a region or country with a high prevalence of tuberculosis.
* Previous Mantoux reaction of 15mm of greater.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01169935
Study Brief:
Protocol Section:
NCT01169935