Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy: A Cohort Study Using US Electronic Medical Record Data
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 365,000
- 试验地点
- 2
- 主要终点
- Pregnancy outcome: Still birth/fetal demise
研究概览
简要总结
The purpose of this study is to evaluate the safety of Adacel vaccine among pregnant individuals exposed to Adacel at any point between the 1st day of the 27th week of gestation up to the end of pregnancy and their offspring (ie, Adacel-exposed cohort), in comparison with pregnant individuals not vaccinated with any Tdap vaccines during pregnancy and their offspring (ie, Tdap-unvaccinated comparator cohort).
The primary objectives are to estimate incidence rates and relative risks for each prespecified pregnancy outcome in Adacel-exposed and Tdap-unvaccinated comparator cohorts and for each prespecified adverse birth outcome in the offspring of both cohorts.
The secondary objectives are to estimate incidence rates and relative risks for each prespecified adverse fetal and neonatal outcome in the offspring of Adacel-exposed and Tdap unvaccinated comparator cohorts and for each prespecified adverse outcome for pregnant individuals in both cohorts.
详细描述
This is a retrospective cohort study utilizing existing EHR data to identify eligible pregnant individuals, with an observation period spanning January 2016 through December 2024. Given this study design, follow-up for all pregnancies with documented deliveries is expected to be complete by December 2025.
The study report is expected to be completed by 31 December 2026.
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
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For pregnant individuals:
- •Continuous enrollment, with no more than a 1-month administrative gap from 90 days prior to their last menstrual period (LMP)
- •Continuous enrollment for the duration of their pregnancy through delivery or termination of pregnancy (or 6 weeks postpartum for preeclampsia/eclampsia and 28 days for PPH) unless censored at death in order to capture study outcomes
- •At least 1 prenatal visit prior to 27 weeks of gestation during pregnancy
- •For offspring:
- •Infants delivered by pregnant individuals who meet all the inclusion criteria above
- •With gestational age as calculated based on date of birth recorded in the EMR
排除标准
- •For pregnant individuals:
- •Loss of pregnancy or with delivery before 27 weeks of gestation
- •Vaccinated with Boostrix® (Tdap vaccine, GSK), or with an unknown brand of Tdap vaccine, or Td (tetanus, diphtheria) vaccine during pregnancy
- •Vaccinated with any Tdap vaccine prior to the ACIP recommended optimal timeframe of ≥ 27 0/7 weeks of gestation
- •Received more than one Tdap vaccine during pregnancy
- •Vaccinated with one or more live vaccines during pregnancy
- •Pregnant individuals with multiple gestation pregnancies (eg, twins, triplets)
- •For offspring:
- •Infants delivered by pregnant individuals who meet any of the exclusion criteria above
研究组 & 干预措施
Adacel-Exposed Cohort
Cohort will include all pregnant individuals with a record of Adacel vaccination during the third trimester of pregnancy (ie, first day of 27th week of gestation up to the end of pregnancy) and their offspring
干预措施: Not applicable / database analysis (Other)
Tdap-Unvaccinated Comparator Cohort
Cohort will include all pregnant individuals meeting eligibility criteria and with no record of any Tdap vaccination from pregnancy onset date until the end of pregnancy and their offspring
干预措施: Not applicable / database analysis (Other)
结局指标
主要结局
Pregnancy outcome: Still birth/fetal demise
时间窗: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of still birth/fetal demise in Adacel-exposed and Tdap-unvaccinated comparator cohorts
Birth outcome: Low birth weight
时间窗: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of low birth weight in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts
Birth outcome: Preterm birth
时间窗: From 1st day of the 27th week of gestation and less than 37 weeks gestation
Incidence rates of preterm birth in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts
Birth outcome: Small for gestational age
时间窗: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of small for gestational age in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts
Pregnancy outcome: Live birth
时间窗: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of live births in Adacel-exposed and Tdap-unvaccinated comparator cohorts
Pregnancy outcome: Therapeutic abortion
时间窗: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of therapeutic abortion in Adacel-exposed and Tdap-unvaccinated comparator cohorts
次要结局
- Adverse neonatal outcome: Congenital anomalies(From birth up to 28 days post-birth)
- Adverse fetal outcome: Fetal growth arrest (restriction)(From 1st day of the 27th week of gestation up to 42 weeks gestation)
- Adverse outcomes in pregnant individuals: Chorioamnionitis(From 1st day of the 27th week of gestation up to 42 weeks gestation)
- Adverse neonatal outcome: Neonatal death(From birth up to 28 days post-birth)
- Adverse neonatal outcome: Neonatal sepsis(From birth up to 28 days post-birth)
- Adverse outcomes in pregnant individuals: Preterm labor(From 1st day of the 27th week of gestation and less than 37 weeks gestation)
- Adverse outcomes in pregnant individuals: Preeclampsia/eclampsia(From 1st day of the 27th week of gestation up to 42 days postpartum)
- Adverse outcomes in pregnant individuals: Postpartum hemorrhage(Within 24 hours of delivery up to 28 days postpartum)
- Adverse outcomes in pregnant individuals: Placental abruption(From 1st day of the 27th week of gestation up to 42 weeks gestation)
- Adverse outcomes in pregnant individuals: Premature rupture of membranes(From 1st day of the 27th week of gestation up to 42 weeks gestation)
- Adverse neonatal outcome: Neonatal respiratory distress(From birth up to 28 days post-birth)
- Adverse neonatal outcome: Neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia(From birth up to 28 days post-birth)