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临床试验/NCT02567747
NCT02567747已完成不适用

Impact of Vaccination Against Pneumococcal Disease on the Morbidity of Acute Otitis Media in Colombian Children < 5 Years of Age

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
1
主要终点
Occurrence of reported cases of AOM in children below 5 years of age, in post-vaccination period compared to pre-vaccination period of PCV vaccination in UMV

研究概览

简要总结

The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health care resources before and after the introduction of vaccination against pneumococcal disease within the Universal Mass Vaccination (UMV) in Colombia.

研究设计

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

入排标准

年龄范围
— 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged less than five years with record of acute otitis media (with ICD-10 codes: H65 to H66) AND/OR.
  • Children aged less than five years with record of pneumonia (with ICD-10 codes: J13 to J18) AND/OR.
  • Children aged less than five years with any ICD-10 codes for respiratory diseases (J00-J99).

排除标准

  • Not applicable

结局指标

主要结局

Occurrence of reported cases of AOM in children below 5 years of age, in post-vaccination period compared to pre-vaccination period of PCV vaccination in UMV

时间窗: Up to 7 years : from January 2008 to December 2014

次要结局

  • Occurrence of reported cases of pneumonia and acute respiratory infections, overall and by morbidity, age groups, and department in children below 5 years of age before and after implementation of PCV vaccination into the UMV(Up to 7 years : from January 2008 to December 2014)
  • Occurrence of reported deaths due to pneumonia and acute respiratory infections by age group (0-24 months and 25-59 months), department and overall in children below 5 years of age before and after implementation of PCV vaccination into the UMV(Up to 7 years : from January 2008 to December 2014)
  • Occurrence of reported cases of AOM in children by morbidity, age group, and department in children in post-vaccination period compared to pre-vaccination period of PCV vaccination(Up to 7 years : from January 2008 to December 2014)
  • Occurrence of AOM related health care resources used and costs* before and after implementation of PCV vaccination into UMV by age group (0-24 months and 25-59 months) and overall(Up to 7 years : from January 2008 to December 2014)
  • Total number of doses (complete or partial) of PCV vaccination administered in infants <1year of age after its introduction into the UMV program in Colombia.(Up to 7 years : from January 2008 to December 2014)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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