跳至主要内容
临床试验/NCT01694329
NCT01694329Unknown不适用

Impact of Introduction of PHiD-CV (Pneumococcal Nontypeable H. Influenza Protein D-conjugate Vaccine) for Nunavik Children, Quebec, Canada

CHU de Quebec-Universite Laval1 个研究点 分布在 1 个国家目标入组 1,420 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,420
试验地点
1
主要终点
Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.

研究概览

简要总结

The objective of this study is to document the residual burden of acute upper respiratory infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and auditory functional and anatomical abnormalities in children under the age of 5 years in Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996) and those exposed to PCV-7 exclusively (those born in 2003-2007).

详细描述

Around 1420 children born between 2006 and 2010 had been eligible to routine immunization program with pneumococcal vaccines.

The objective of this study is to document the residual burden of acute upper respiratory infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and auditory functional and anatomical abnormalities in children under the age of 5 years in Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996) and those exposed to PCV-7 exclusively (those born in 2003-2007).

The specific objectives are to measure in children under the age of 5 years in Nunavik and born in the period 2009 to 2010:

  1. the incidence of invasive pneumococcal disease(IPD), AURIs, ALRIs and OMs;
  2. the frequency of antibiotic treatments due to these diseases;
  3. the frequency of hospitalizations and transfers to the South on account of ALRIs;
  4. the frequency of tympanotomies and ventilation tube insertions;
  5. the prevalence of anatomical and functional lesions of the middle ear at the age of 5 years (the main issue).

The main research hypothesis is that the incidence of AURIs, ALRIs and OMs and the prevalence of sequelae from OM decreased after the implementation of PHiD-CV in 2009, as compared with previous cohorts of children who were not exposed to this new vaccine.

研究设计

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

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Born between 2006 and 2010
  • Resident in Nunavik (province of Quebec, Canada)

排除标准

  • Not applicable

结局指标

主要结局

Prevalence of anatomical and functional lesions of the middle ear at the age of 5 years.

时间窗: at age of 5 years old

次要结局

  • Incidence of IPDs(at age of 5 years old)
  • Frequency of antibiotic treatments due to diseases of interest(at age of 5 years old)
  • Frequency of hospitalizations and transfers to the South on account of ALRIs(at age of 5 years old)
  • Frequency of tympanotomies and ventilation tube insertions(at age of 5 years old)
  • Incidence of AURIs(at age of 5 years old)
  • Incidence of ALRIs(at age of 5 years old)
  • Incidence of OMs(at age of 5 years old)

研究者

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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