Not applicable / database analysis: Not applicable / database analysis
Study summary
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.
Eligibility
Sex
FEMALE
Min age
15 Years
Max age
49 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Pregnancy outcome: Live birth — 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: Still birth/fetal demise — 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
Pregnancy outcome: Therapeutic abortion — 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
Birth outcome: Preterm birth — 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: Low birth weight — 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: Small for gestational age — 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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