PREVENAR 20 SUSPENSION LIQUID FOR INJECTION SPECIAL INVESTIGATION - Investigation in Infants Starting Vaccination at the Age of 2 Month, Inclusive, to 7 Months, Exclusive -
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Percentage of Participants Reporting Adverse Reactions(ADRs)
研究概览
简要总结
The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.
This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.
Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age.
Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination.
The side effects observed in the participants will be recorded and looked into.
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
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 2 months, inclusive, to 7 months, exclusive
- •Those without a history of pneumococcal vaccination including PREVENAR 20
- •Those who are expected to receive 4 doses
- •Those whose parent or legal guardian understands the details of the study and provides consent to provision of information collected in the study to third parties and use of the information for other purposes.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
20-valent Pneumococcal Conjugate Vaccine
Infants aged 2 months, inclusive to 7 months, exclusive who have been vaccinated with PREVENAR 20 for the first time.
干预措施: 20-valent Pneumococcal Conjugate Vaccine (Biological)
结局指标
主要结局
Percentage of Participants Reporting Adverse Reactions(ADRs)
时间窗: From the first day of each vaccination (1st-4th) up to 28 days after each vaccination (1st-4th).
Percentage of Participants Reporting Serious Adverse Reactions (SADRs)
时间窗: From the first day of 1st vaccination up to 28 days after 4th vaccination.
次要结局
未报告次要终点