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临床试验/NCT01109108
NCT01109108已完成不适用

Streptococcus Pneumonia: Herd Effects and Emergence of Potentially Virulent Serotypes PCV13_Impact of NP Colonization, Herd Effects and Emergence of Potentially Virulent Serotypes of Pneumococci

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9,000
试验地点
1
主要终点
Nasopharngeal Colonization With PCV13 S. Pneumoniae

研究概览

简要总结

The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children < 5.

Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to participate

排除标准

  • children with facial malformations making NP sampling unacceptable
  • children in foster care

结局指标

主要结局

Nasopharngeal Colonization With PCV13 S. Pneumoniae

时间窗: Study years 1-5

Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Pelton

Professor of Pediatrics and Epidemiology

Boston Medical Center

研究点 (1)

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