SPECIAL INVESTIGATION FOR ABRYSVO INTRAMUSCULAR INJECTION -INVESTIGATION IN INDIVIDUALS AGED 60 YEARS OR OLDER-
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 individuals aged 60 years or older reporting Serious Adverse Reactions from the day of vaccination up to 28 days after vaccination.
研究概览
简要总结
This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Those who have previously participated in the clinical trials of this product will be excluded.
- •Vaccinated participants (or his/her legally acceptable representative) who understand the information on this study and have provided written consent regarding their participation in the study.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
RSVpreF vaccine
Individuals aged 60 years or older who has been vaccinated with Abrysvo for the first time.
干预措施: RSVpreF vaccine (Biological)
结局指标
主要结局
Percentage of individuals aged 60 years or older reporting Serious Adverse Reactions from the day of vaccination up to 28 days after vaccination.
时间窗: From the day of vaccination up to 28 days after vaccination.
Serious adverse reaction in individuals aged 60 years or older will be assessed.
Percentage of individuals aged 60 years or older reporting Adverse Reactions for 28 days after vaccination.
时间窗: From the day of vaccination up to 28 days after vaccination.
Adverse reaction (including serious) in individuals aged 60 years or older will be assessed.
次要结局
未报告次要终点