NCT01214538Unknown不适用
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
NasVax Ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serological studies of pneumococcal proteins and their development over time following otitis media infections
研究概览
简要总结
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Jewish and Bedouin children.
- •Patients can be either ambulatory or hospitalized.
- •Presenting with acute otitis media.
- •Tympanocentesis was performed at least in one ear for a clinical indication.
- •Culture of middle ear fluid was obtained.
- •Parents agreeing to participate in the study and to submit their children for follow-up, blood test and nasopharyngeal/oropharyngeal (NP/OP) cultures.
排除标准
- •Having another infection that is likely to be caused by S. pneumoniae.
- •Known immunodeficiency.
- •Known previous recent pneumococcal infections (<1 month prior to current visit).
结局指标
主要结局
Serological studies of pneumococcal proteins and their development over time following otitis media infections
时间窗: 3 months per individual
The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.
次要结局
未报告次要终点
研究者
研究点 (1)
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