An observational study in Tuberculosis, Pulmonary, sponsored by Bill & Melinda Gates Medical Research Institute. Completed at 36 sites in 14 countries. Open to participants aged 15 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Bill & Melinda Gates Medical Research Institute · Observational
The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's enrollment of 7,203 is above the median of 300 across 83 observational studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Bill & Melinda Gates Medical Research Institute is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A maximum of 7,203 participants who are at high risk of Mtb infection and TB (disease) will be enrolled.
Inclusion Criteria: Capable of giving signed and informed assent (as appropriate), which includes compliance with the requirements listed in the informed consent form (ICF) and informed assent form (IAF)
Between 15 and 34 years of age (inclusive)
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:
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])
History of previous administration of an experimental Mtb vaccine
Unstable / uncontrolled chronic condition according to the judgment of the investigator
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IGRA status per site
Proportion of participants with a positive IGRA, per site, calculated using per protocol population. 95% CI will summarize the precision associated with the estimate.
Time frame: Screening
IGRA status by age group per site
Proportion of participants with a positive IGRA, by age group (15 to 24 \[inclusive\], and 25 to 34 years of age \[inclusive\]) per site, calculated using per protocol population. 95% CI to summarize the precision associated with the estimates.
Time frame: Screening
Suspected pulmonary TB during follow-up period
Incidence rate of participants with suspected TB to be summarized by country. Exact 95% CI to be provided
Time frame: Day 1 up to 30 months
Laboratory-confirmed pulmonary TB during follow-up period
Incidence rate of participants with suspected TB to be summarized by country. Exact 95% CI to be provided.
Time frame: Day 1 up to 30 months
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Sep 2023, 20 months.
Of 44 observational studies under Tuberculosis, Pulmonary, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Bill & Melinda Gates Medical Research Institute