Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of pregnant women with maternal adverse events
研究概览
简要总结
The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy
详细描述
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 of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry.
- •Reports of Dengvaxia pregnancy exposure must contain the following information to be included in the registry:
- •Sufficient evidence to confirm the case qualifies as "exposed during pregnancy";
- •Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures).
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Pregnant women and their offspring(s)
Women and their offspring(s) exposed to Dengvaxia during pregnancy
干预措施: Dengue Tetravalent Vaccine, Live (Biological)
结局指标
主要结局
Percentage of pregnant women with maternal adverse events
时间窗: From vaccination until end of follow-up (maximum 22 months after cohort entry)
Maternal adverse events are reported as serious or non-serious
Pecentage of women with obstetrical adverse events
时间窗: From vaccination until 1 month post-delivery
Obstetrical adverse events are collected during pregnancy, labour, delivery and puerperium, and are reported as serious or non-serious
Percentage of participants with adverse pregnancy outcome
时间窗: On day of birth
Adverse pregnancy outcomes include ectopic pregnancy, elective/induced abortion with no fetal defect(s) or fetus status unknown, elective/induced abortion with fetal defect(s), spontaneous abortion/miscarriage (\<20 weeks), stillbirth/fetal death at 20-27 weeks, fetal death at ≥28 weeks, and fetal death due to maternal death
Percentage of offsprings with infant adverse events
时间窗: From 29 days to 365 days post-birth
Infant events are reported as serious or non-serious
Percentage of offsprings with neonatal adverse events
时间窗: From day of birth to 28 days post-birth
Neonatal events are reported as serious or non-serious
次要结局
未报告次要终点