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 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT00679159
Eligibility Criteria:
Inclusion Criteria:
* Eligible subjects will be children or infants aged 6 months - 11 years.
* Subject's parent/guardian is willing and able to give written informed consent for participation in the study.
* Subject is BCG vaccinated within the first 4 weeks of life
* In addition, informed assent will be obtained from all children aged 7 years or older unless they are adjudged incapable of understanding the basic concepts covered in the informed assent form, and an attempt will be made to obtain informed assent from children aged younger than 7 years if they are judged capable of understanding the basic concepts covered in the informed assent form
* Subject is in good health
* Subject has clinically acceptable laboratory results from screening visit
* CXR normal with no evidence of active or past TB
* Subject's parent/legal guardian is willing to allow child to undergo an HIV test
* Parent/guardian and subject able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion Criteria:
* Subject is Mantoux (\>10 mm) and/or ELISPOT (\> 50 spots/million PBMC) positive for M tb (PPD, ESAT 6 and/or CFP10)
* Subject is HIV antibody positive
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient/subject at risk because of participation in the study, or may influence the result of the study, or the patient/subject's ability to participate in the study.
* Patient/subjects/healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks
* Patient/subjects previously enrolled into this study.
* Received a live vaccine (e.g. measles) in the previous 4 weeks or due to receive a live vaccine in the 4 weeks following enrolment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
11 Years
Study:
NCT00679159
Study Brief:
Protocol Section:
NCT00679159