Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 主要终点
- Number of cases and outcomes of pregnancies following exposure to QIV ID vaccine.
研究概览
简要总结
The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.
详细描述
Sanofi Pasteur will encourage registration of pregnant women exposed to Fluzone QIV-ID in the Sanofi Pasteur Pregnancy Registry by providing the registry's toll-free number, 1-800-VACCINE (1-800-822-2463), in the USPI. The toll-free number will also be available through the Sanofi Pasteur-sponsored Website for the Pregnancy Registry. Both the United States product insert (USPI) and Website will advise health care providers to register women who are pregnant or became aware they were pregnant at the time of Fluzone QIV-ID immunization.
Descriptive statistical methods will be the primary approach for summarizing data from the Fluzone QIV-ID Pregnancy Registry. No vaccine products will be provided or administered as part of this registry protocol.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women will be enrolled in the registry prospectively (after exposure to a product but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry, but they will be analyzed separately from prospective reports.
排除标准
- 未提供
结局指标
主要结局
Number of cases and outcomes of pregnancies following exposure to QIV ID vaccine.
时间窗: Up to six years
Data will be summarized using descriptive statistical methods and stratified by pregnancy outcome (spontaneous abortion, elective termination, fetal death stillbirth, live birth) and timing of vaccine exposure. Infant outcomes include birth defects and physical and social development.
次要结局
未报告次要终点