A Post-Marketing, Observational, Comparative Safety Study of the Novartis Pandemic Influenza A (H1N1) Vaccine(s) in Pregnant Women Versus Non-Vaccinated Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,529
- 试验地点
- 1
- 主要终点
- Low birth weight
研究概览
简要总结
The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome
- •Consents to participate in the study
排除标准
- •Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest
- •Does not consent to participate in the study
- •Has received a non-Novartis pandemic influenza vaccinee
结局指标
主要结局
Low birth weight
时间窗: 3 months follow-up on all live births
Neonatal mortality
时间窗: 3 months follow-up on all live births
Normal live-born delivery
时间窗: 3 months follow-up on all live births
Spontaneous and elective abortions
时间窗: 3 months follow-up on all live births
Congenital malformations
时间窗: 3 months follow-up on all live births
Pre-term birth (prematurity)
时间窗: 3 months follow-up on all live births
次要结局
- Maternal complications of gestational diabetes, preeclampsia, maternal death(During pregnancy and post delivery)