A Pregnancy Registry to Evaluate the Safety of Dengue Vaccine Among Inadvertently Exposed Pregnant Women and Their Offsprings (DNG16)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 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
Primary Objective:
To evaluate the safety of CYD-TDV in pregnant women and their offsprings inadvertently exposed during pregnancy or up to 30 days preceding their last menstrual period (LMP) with regards to maternal, pregnancy, birth, neonatal and infant outcomes. Specifically, the frequency/rates of these outcomes will be: (i) described, and (ii) compared with population-level background incidence rates prior to the introduction of CYD-TDV immunization (i.e., external unvaccinated comparator).
Secondary Objective:
To describe:
- the characteristics of women exposed to CYD-TDV during pregnancy or up to 30 days before the LMP
- the characteristics of CYD-TDV pregnancy exposure with regards to number of doses, dose intervals, and trimester of exposure.
详细描述
This is a non -interventional (observational) post authorization safety study (PASS): no vaccine will be administered as part of the study.
This pregnancy registry study is a combination of a retrospective (outcomes occurred before the start of participant enrollment) and prospective (outcomes occurred after the start of participant enrollment) cohort study using active identification and enrollment of pregnant women and their offsprings inadvertently exposed to CYD-TDV during pregnancy or up to 30 days preceding the LMP.
The study period will be from July 2016 (first availability of Paraná's Immunization Registry) to July 2022 (end of last follow-up interview for offsprings), and the participant enrollment period will last approximately 1 year.
Study duration per participant will vary depending on: 1) the stage of pregnancy at the time the participant will be enrolled; 2) whether the participant will be included retrospectively or prospectively. The maximum duration will be 22.5 months (up to 9 months of pregnancy + 42 days post-delivery [puerperium period] + 12 months post-birth).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort I: CYD-TDV exposed pregnant women and offspring
Pregnant women of any age and their offspring who were inadvertently exposed to CYD-TDV anytime during the pregnancy or in the 30 days preceding their LMP
干预措施: CYD-TDV Dengue Vaccine (Drug)
结局指标
主要结局
Percentage of pregnant women with maternal adverse events
时间窗: From cohort entry up to 42 days post-end of pregnancy
Maternal adverse events defined as all reported adverse events following immunization (serious and non-serious) occurring independent of the pregnancy (e.g., injection site reactions, systemic reactions)
Percentage of pregnant women with pregnancy related adverse events
时间窗: From cohort entry to up to 42 days post-end of pregnancy
Pregnancy related adverse events defined as adverse event of special interest (AESI)s and other reported adverse events (serious and non-serious) occurring during the pregnancy, labour and delivery, or the puerperium
Percentage of offsprings with adverse neonatal events
时间窗: From DOB up to 28 days post-birth
Adverse neonatal events defined as study AESIs and other reported adverse events (serious and non-serious) occurring between DOB and 28 days post-DOB
Percentage of offsprings with adverse birth outcomes
时间窗: On day of birth (DOB)
Adverse birth coutcomes defined as study AESIs and other reported adverse events (serious and non-serious) observed or diagnosed at birth
Percentage of offsprings with adverse infant events
时间窗: From day 29 post-birth up to 12 months post-birth
Adverse infants events defined as study AESIs and other reported adverse events (serious and non-serious) occurring between day 29 post-birth and 12 months post-birth
次要结局
未报告次要终点