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Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)

2021年2月3日 更新者：Arto Palmu

Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (实际的)

2341

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 芬兰
      • Tampere、芬兰
        • National Institute for Health and Welfare

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3年 至 7年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Non-PCV-vaccinated 3 to 7 year-old siblings living in the same household with a younger child vaccinated in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Sibling vaccinated with PCV GSK1024850A

Older sibling of a child vaccinated with Pneumococcal conjugate vaccine GSK1024850A in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)
生物：PCV GSK1024850A
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
其他名称：
  • GSK Biologicals' Synflorix TM vaccine
Control-vaccinated sibling

Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)
生物：hepatitis B vaccine or hepatitis A vaccine
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
其他名称：
  • GSK Biologicals' Engerix TM (hepatitis B) vaccine
  • GSK Biologicals' Havrix TM (hepatitis A) vaccine

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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
one sampling at 3 to 7 years of age

次要结果测量

结果测量
措施说明
大体时间
Carriage Due to Any Pneumococcal Serotype
大体时间：one sampling at 3 to 7 years of age
Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
one sampling at 3 to 7 years of age
Carriage Due to Haemophilus Influenzae
大体时间：one sampling at 3 to 7 years of age
Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
one sampling at 3 to 7 years of age
Invasive Pneumococcal Disease
大体时间：Up to 8 years
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Up to 8 years
Hospital-diagnosed Pneumonia
大体时间：Up to 8 years
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Up to 8 years
Tympanostomy Tube Surgery
大体时间：Up to 8 years
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Up to 8 years
Outpatient Antibiotic Treatment
大体时间：Up to 8 years
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Up to 8 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Arto Palmu

合作者

GlaxoSmithKline

调查人员

  • 首席研究员：Arto A Palmu, M.D.、Finnish Institute for Health and Welfare

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年4月1日

初级完成 (实际的)

2013年6月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2011年3月7日

首先提交符合 QC 标准的

2011年3月7日

首次发布 (估计)

2011年3月9日

研究记录更新

最后更新发布 (实际的)

2021年3月1日

上次提交的符合 QC 标准的更新

2021年2月3日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • THL/1843/6.02.01/2010

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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