NCT00523770已完成不适用
An Exploratory Study in Healthy Elderly Subjects to Collect Urine for the Development of Assays to Detect Streptococcus Pneumoniae.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Positive or negative result using Binax NOW S. pneumoniae Test
研究概览
简要总结
GSK Biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Some tests on urine are already on the market but need to be improved in the laboratory. For that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 65 and 85 years of age at the time of the study.
- •Written informed consent obtained from the subject
- •Healthy subjects as established by medical history and clinical examination before entering into the study
排除标准
- •Previous vaccination against Streptococcus pneumoniae in the 3 months before study start,
- •History of pneumonia confirmed by documented radiology or any other diagnostic method within 3 months prior to study start
结局指标
主要结局
Positive or negative result using Binax NOW S. pneumoniae Test
时间窗: within one day
次要结局
- Positive or negative result using the test to be developed for typing of S. pneumoniae(within one day)
- Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi)(within one day)
研究者
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