None listed
Conditions
Interventions
None listed
Sponsors
Bill & Melinda Gates Medical Research Institute (Gates MRI)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent and informed assent (as appropriate), which includes compliance with the requirements listed in the informed consent form (ICF) and informed assent form (IAF) 2. Between 15 and 34 years of age (inclusive) 3. Participants who agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary and have no current plans to relocate from the study area for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. History of active TB within the last 24 months (i.e., 24 months from end of treatment to day of screening, based on history [no documentation required]) 2. History of previous administration of an experimental Mtb vaccine 3. Unstable/uncontrolled chronic condition according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with positive IGRA, per site, calculated using the per protocol population.Timepoint: IGRA status (positive/negative/indeterminate) at screening (i.e) Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with positive IGRA, summarized by age group (15 to 24 [inclusive], and 25 to 34 years of age [inclusive]) per site. 2. Incidence rate of suspected pulmonary TB, summarized overall. 3. Incidence rate of laboratory-confirmed pulmonary TB, summarized overall.Timepoint: 1. Time Frame: Screening 2. Time Frame: Day 1 up to 30 months 3. Time Frame: Day 1 up to 30 months | — |
Countries
Bangladesh, Brazil, Democratic Republic of the Congo, Gambia, India, Kenya, Mozambique, Peru, Philippines, South Africa, Uganda, Viet Nam, Zambia
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
Outcome results
None listed