Post-Licensure Database Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96,175
- 试验地点
- 1
- 主要终点
- Incidence Rates of Pregnancy Outcome Events
研究概览
简要总结
Primary Objective:
To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the estimated date of conception with regards to pregnancy, birth, and neonatal/infant outcomes
Secondary Objective:
详细描述
Data will be recorded prospectively during the safety follow-up for pregnant women until delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1 year after birth.
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
- — 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence Rates of Pregnancy Outcome Events
时间窗: From start of pregnancy or up to 28 days prior to conception until delivery or pregnancy outcome
Pregnancy outcome events: spontaneous abortion, preterm labor, stillbirth/Fetal death, congenital/fetal anomalies detected during pregnancy, eclampsia, and placental abruption
Incidence Rates of Birth Events
时间窗: At birth
Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth
Incidence Rates of Neonatal/ Infant Outcomes
时间窗: From birth to Day 365 post-birth
Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive
次要结局
未报告次要终点