NCT05190146已完成不适用
A Multi-country, Epidemiologic Study to Assess the Interferon Gamma Release Assay (IGRA) Positivity, and to Build Capacity to Conduct a Tuberculosis (TB) Vaccine Efficacy Study, in Populations With a High TB Disease Burden
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,203
- 试验地点
- 1
- 主要终点
- IGRA status per site
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 34 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
- •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.
排除标准
- •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
结局指标
主要结局
IGRA status per site
时间窗: Screening
Proportion of participants with a positive IGRA, per site, calculated using per protocol population. 95% CI will summarize the precision associated with the estimate.
次要结局
- IGRA status by age group per site(Screening)
- Laboratory-confirmed pulmonary TB during follow-up period(Day 1 up to 30 months)
- Suspected pulmonary TB during follow-up period(Day 1 up to 30 months)
研究者
研究点 (1)
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