NCT01808365已完成不适用
Neisseria Meningitidis Carriage Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs
研究概览
简要总结
This carriage study aims to evaluate the presence of meningococcus in Asian populations (and potential for disease) and explore the extent and serogroup distribution of meningococci circulating in the population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
- •Asymptomatic subjects attending a school or university.
- •A male or female between, and including 5 and 24 years of age at the time of enrollment.
排除标准
- •Subjects who have received a meningococcal conjugate vaccine.
- •Use of any investigational or non-registered product within one week before the enrollment visit.
- •Acute respiratory tract infection within 14 days of sample collection.
- •Immune deficiencies, haematological disorders and oncological disease.
- •Use of steroids or immunosuppressant drugs within 14 days of sample collection.
- •Administration of antibiotics within the 2 weeks preceding the collection of sample.
- •Cranio-facial malformations prohibiting the collection of posterior pharyngeal swabs.
- •Child in care.
结局指标
主要结局
Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs
时间窗: At enrollment (Day 0)
次要结局
- Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing(At enrollment (Day 0))
- The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies(At enrollment (Day 0))
研究者
研究点 (1)
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