CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,062
- 试验地点
- 1
- 主要终点
- Risk of preterm birth following RSV vaccine exposure
研究概览
简要总结
The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal/infant outcomes, following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation in the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry (RSV-PR)? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.
The secondary study objective is to estimate the risk of other safety outcomes of interest following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including:
- Pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes, preterm premature rupture of membranes, cesarean delivery, prolonged maternal duration of hospital stay
- Maternal outcomes: thrombocytopenia, Guillain-Barré syndrome, other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death
- Neonatal/infant outcomes: small for gestational age, large for gestational age, low birth weight, admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth at 1 year of age The exploratory study objective is to describe the most frequently reported maternal adverse events following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.
详细描述
Rationale and background: Respiratory syncytial virus (RSV) vaccine is approved for use in pregnant individuals during late pregnancy (32 weeks, 0 days through 36 weeks, 6 days of gestation) to prevent RSV-related severe lower respiratory tract disease in infants from birth through 6 months of age.
Research question and objectives: This work is intended to answer the question regarding what is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal/infant outcomes, following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders of pregnancy following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.
The secondary study objective is to estimate the risk of other safety outcomes of interest following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including:
- Pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes (PROM), preterm premature rupture of membranes (PPROM), cesarean delivery, prolonged maternal duration of hospital stay
- Maternal outcomes: thrombocytopenia, Guillain-Barré syndrome (GBS), other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death
- Neonatal/infant outcomes: small for gestational age (SGA), large for gestational age, low birth weight (LBW), admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth deficiency at 1 year of age The exploratory study objective is to describe the most frequently reported maternal adverse events (AEs) occurring within 42 days of RSV vaccine administration between 32 weeks, 0 days and 36 weeks, 6 days of gestation.
Outcomes occurring before 32 weeks, 0 days of gestation, including but not limited to spontaneous abortion and major congenital malformations, will not be evaluated.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals must meet the following inclusion criteria to be eligible for inclusion in the study:
- •A resident of the US at enrollment
- •18 to 50 years of age at enrollment
- •Gestational age of ≥32 weeks, 0 days at enrollment
- •If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
- •Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB/independent ethics committee, verbal consent indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- •Authorization obtained for the relevant HCP(s) to provide data to the registry
- •Contact information available (for participant and HCPs)
排除标准
- •Individuals meeting any of the following criteria will not be included in the study:
- •Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation
- •Multi-fetal pregnancy
- •Enrolled in the RSV-PR with a previous pregnancy
结局指标
主要结局
Risk of preterm birth following RSV vaccine exposure
时间窗: 36 weeks, 6 days
Risk of preterm birth following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
Risk of hypertensive disorders following RSV vaccine exposure
时间窗: 42 days after date of vaccination
Risk of hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
次要结局
- Risk of other safety outcomes of interest following RSV vaccine exposure(42 days after date of vaccination)
- Frequently reported maternal adverse events following RSV vaccine exposure(42 days after date of vaccination)