Special Investigation for ABRYSVO Intramuscular Injection -Investigation in Pregnant Women and Infants-
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
- 497
- 试验地点
- 1
- 主要终点
- Percentage of infants reporting Adverse Reactions from the birthday up to 28 days after birth
研究概览
简要总结
This post-marketing study is a multicenter cohort study in pregnant women vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in pregnant women and their infants 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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Pregnant women who have previously participated in the clinical trials of Abrysvo will be excluded.
- •Vaccinated participants who have provided written consent regarding their participation in the study and entry of symptoms to ePRO with the use of their devices (smartphones, tablets PC, etc.) (or paper-PRO if there is any compelling reason) upon understanding the explanatory document. For a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent.
- •Pregnant women who have provided written consent to the participation of their infants in the study. For a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
RSVpreF vaccine
Pregnant women who have 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 infants reporting Adverse Reactions from the birthday up to 28 days after birth
时间窗: up to 28 days after birth
Percentage of infants reporting Serious Adverse Reactions from the birthday up to 28 days after birth
时间窗: up to 28 days after birth
Percentage of pregnant women reporting Adverse Reactions for 28 days after vaccination
时间窗: up to 28 days after vaccination
Percentage of pregnant women reporting Serious Adverse Reactions from the day of vaccination up to 28 days after delivery
时间窗: up to 28 days after delivery
Percentage of pregnant women reporting reactogenicity events (local reactions and systemic events) from day of vaccination up to 7 days after vaccination
时间窗: up to 7 days after vaccination
次要结局
未报告次要终点