NCT02258178撤回不适用
Flucelvax Pregnancy Registry: an Observational Study on the Safety of Flucelvax Exposure in Pregnant Women and Their Offspring
Seqirus1 个研究点 分布在 1 个国家开始时间: 2014年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- major congenital malformation
研究概览
简要总结
The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy women pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes.
- •Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy
- •Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
- •Date the pregnancy exposure is registered
- •Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc) The primary population for analysis will include prospectively enrolled pregnancies exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that meet the minimum criteria for evaluation)
排除标准
- •Invalid registry reports and pregnancies deemed lost to follow-up will be excluded from the primary analysis. Retrospective reports will not be included, although retrospective cases with MCMs will be reviewed and reported separately.
结局指标
主要结局
major congenital malformation
时间窗: From time of enrollment during pregnancy to time of delivery or pregnancy termination
preterm birth
时间窗: From time of enrollment during pregnancy to time of delivery or pregnancy termination
low birth weight
时间窗: From time of enrollment during pregnancy to time of delivery or pregnancy termination
次要结局
未报告次要终点
研究者
研究点 (1)
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