NCT04912297已完成不适用
Persistence of Humoral Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With the 10-valent Pneumococcal Conjugate Vaccine in Finland
Finnish Institute for Health and Welfare1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2009年11月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Persistence of Humoral Immunity Following PCV10 Vaccination
研究概览
简要总结
The aim of the study are to assess the persistence of immunity against vaccine serotypes (VSTs) and vaccine-related serotypes in PCV10 vaccinated children in Finland.
详细描述
The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed PCV10 vaccination with 3 or 4 doses (2+1 or 3+1 schedule) before blood sampling at age of 13 months
- •Age at sample collection 13 months, 2 years or 3 years
- •PCV10 vaccination received 2-6 weeks before sample collection at the age of 1 year
- •Informed consent obtained covering the planned analyses
排除标准
- •PCV13 or PPV23 dose received
- •Informed consent withdrawn
结局指标
主要结局
Persistence of Humoral Immunity Following PCV10 Vaccination
时间窗: Two years following last PCV10 vaccination
Persistence of humoral immunity to vaccine- and vaccine-related pneumococcal serotypes after vaccination with PCV10. The serotype 19A specific geometric mean IgG antibody concentrations are reported as micrograms per ml with 95% confidence intervals.
次要结局
未报告次要终点
研究者
研究点 (1)
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