Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,341
- 试验地点
- 1
- 主要终点
- Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules
研究概览
简要总结
The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.
详细描述
The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.
This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2011 and a register-based follow-up study for invasive disease, hospital-diagnosed pneumonia, tympanostomy tube surgery and outpatient antimicrobial treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 3 to 7 years
- •younger sibling at least 12 months of age living in the same household participates in the FinIP or 053 trial (regardless of the vaccination schedule)
- •at least one parent with fluent Finnish
- •informed consent from one parent
排除标准
- •commercial PCV vaccination administered
- •study-related PCV vaccination administered (open or blind)
- •history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
结局指标
主要结局
Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules
时间窗: one sampling at 3 to 7 years of age
Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
次要结局
- Invasive Pneumococcal Disease(Up to 8 years)
- Carriage Due to Any Pneumococcal Serotype(one sampling at 3 to 7 years of age)
- Outpatient Antibiotic Treatment(Up to 8 years)
- Hospital-diagnosed Pneumonia(Up to 8 years)
- Carriage Due to Haemophilus Influenzae(one sampling at 3 to 7 years of age)
- Tympanostomy Tube Surgery(Up to 8 years)
研究者
Arto Palmu
Head of Clinical Research Unit
Finnish Institute for Health and Welfare