The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of pregnant women with maternal adverse events (AEs)
研究概览
简要总结
Primary Objective:
To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
详细描述
This study is a prospective pregnancy registry to collect and analyze the outcome of exposure to MenQuadfi™ during pregnancy or within 30 days prior to their LMP. The registry will encourage prospective registration, which is defined as registration of a pregnancy exposure prior to knowledge or perceived knowledge of the pregnancy outcome.
Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The eligible population will include pregnant women and their offspring residing in the US and its territories who are exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP, for whom the exposure is reported to the pregnancy registry.
- •Reports of MenQuadfi® pregnancy exposure must contain the following information:
- •Sufficient evidence to confirm that vaccination occurred during the pregnancy or in the 30 days preceding the LMP;
- •Vaccine name (brand or generic) is provided (i.e., MenQuadfi®, Meningococcal vaccine, MenACWY conjugate vaccine), or not specified (eg, meningococcal vaccine from an unknown manufacturer).
排除标准
- •Only post-marketing spontaneous case reports will be included; reports from clinical trials will not be part of the registry.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Pregnant women and their offspring(s)
Pregnant women and their offspring(s) exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP
干预措施: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (Biological)
结局指标
主要结局
Percentage of pregnant women with maternal adverse events (AEs)
时间窗: From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)
Maternal adverse events defined as any reported adverse event (AE), following vaccination of a pregnant woman, occurring independent of the pregnancy (e.g., injection site reactions)
Percentage of pregnant women with obstetrical AEs
时间窗: From vaccination to 28 days after delivery
Obstetrical adverse events defined as any reported AE, following vaccination of a pregnant woman, related directly to the pregnancy (e.g., complications of pregnancy, labor and delivery, and puerperium)
Percentage of pregnant women with pregnancy AEs
时间窗: On day of birth
Pregnancy adverse events defined as any reported AE, following vaccination of a pregnant woman, related to birth outcomes (e.g., live birth, spontaneous abortion/miscarriage, stillbirth/fetal death)
次要结局
- Percentage of offsprings with adverse neonatal AEs(From day of birth to 28 days post-birth)
- Percentage of offsprings with adverse infant AEs(From day 29 post-birth to 365 days post-birth)