Post-marketing Safety Evaluation of 10 or 13-valent Pneumococcal Conjugate Vaccine in Children and 23-valent Pneumococcal Polysaccharide Vaccine in Elderly Adults.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000,000
- 试验地点
- 1
- 主要终点
- Relative risk of adverse events
研究概览
简要总结
The purpose of this observational study is to examine the risk of adverse events following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age <59 months and 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults age 65 years and older.
详细描述
The purpose of this observational study is to examine 1) the risk of adverse events (AEs) following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age <59 months using a self-controlled risk interval design and 2) the risk of AEs following vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults age 65 years and older compared with influenza vaccine recipients using a cohort design. We will use the national health insurance database from the National Health Insurance Service (NHIS) linked with the national immunization program registry data from the Korea Centers for Diseases Control & Prevention (KCDC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children < 5 years who had received PCV10 or PCV13 from May, 2014 to December,
- •Persons 65 years or older who had received at least one dose of PPSV23 or influenza vaccine (as a comparator) between January, 2014 and December, 2018.
排除标准
- •Persons who experienced outcomes of interest within 1 year before the date of vaccination.
结局指标
主要结局
Relative risk of adverse events
时间窗: 2014-2018
1. the ratio of probability of adverse events occuring in the risk periods after vaccination with PCV10 or PCV13 versus the control periods in the self-controlled risk interval study design. 2. the ratio of probability of adverse events occuring in the PPSV23 group versus the influenza vaccine (a comparator) group in the cohort study design.
次要结局
未报告次要终点
研究者
Ju-Young Shin
Associate Professor
Sungkyunkwan University