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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT02795260
Eligibility Criteria:
Inclusion Criteria of the screening crowd
1. 18-65 years old;
2. consent and signed informed consent form;
3. comply with follow-up;
4. No history of tuberculosis;
5. Physical condition:no obvious heart,liver,kidney, digestive tract,nervous system,mental disorder from signed informed consent to the injection;
6. Normal axillary temperature (quiet condition blow 37.0℃)
7. No abnormal chest by X-ray check;
Exclusion Criteria of the screening crowd
1. Has the following serious disease, such as advanced cancer, diabetes, chronic obstructive pulmonary disease (copd) in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc;
2. Epilepsy and psychiatric patients
3. Has known or suspected (or risk possible) immune damaged or abnormal functional , accept glucocorticoid and immunosuppressants or immunopotentiator treatment, outside the gastrointestinal tract protein or blood products or plasma extraction in 3 months；
4. Has acute febrile diseases and infectious diseases;
5. taking part in any other new drug clinical trials or participated in any other new drug clinical trials within 3 months before this trials;
6. a clear history of drug allergy ；
7. In pregnancy or lactation；
8. There is a clear history of high blood pressure and systolic blood pressure ≥180mmHg , and/or diastolic blood pressure of ≥ 100mmHg after drug control ；
9. Researchers consider that any conditions may affect the trial evaluation.
Inclusion Criteria of three negative crowd
1. conforming to the inclusion criteria of the screening crowd ;
2. the result of four detection methods are all the negative: ESAT6-CFP10 、 TB - PPD and specific gamma - IFN and HIV;
Exclusion Criteria of three negative crowd
1. conforming to the exclusion criteria of the screening crowd ;
2. With BCG vaccination taboo .
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02795260
Study Brief:
Protocol Section:
NCT02795260