CTRI/2023/01/048867进行中（未招募）不适用
A multi-country, epidemiologic study to assess the interferon gamma releaseassay (IGRA) positivity, and to build capacity to conduct a tuberculosis (TB) vaccine efficacystudy, in populations with a high TB disease burden
Bill & Melinda Gates Medical Research Institute (Gates MRI)2 个研究点 分布在 1 个国家目标入组 7,520 人开始时间: 2023年1月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7,520
- 试验地点
- 2
- 主要终点
- Proportion of participants with positive IGRA, per site, calculated using the per protocol population.
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
入排标准
- 年龄范围
- 15.00 Year(s) 至 34.00 Year(s)（—）
- 性别
- All
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
Proportion of participants with positive IGRA, per site, calculated using the per protocol population.
时间窗: IGRA status (positive/negative/indeterminate) | at screening (i.e) Day 1
次要结局
- 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.)
研究者
研究点 (2)
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