Pertussis (Whooping Cough)
Conditions
Brief 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.
Detailed description
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.
Interventions
OTHERNot applicable / database analysis
Not applicable / database analysis
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse neonatal outcome: Neonatal death | From birth up to 28 days post-birth | Incidence rates of neonatal death in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse neonatal outcome: Neonatal sepsis | From birth up to 28 days post-birth | Incidence rates of neonatal sepsis in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse neonatal outcome: Neonatal respiratory distress | From birth up to 28 days post-birth | Incidence rates of neonatal respiratory distress in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse neonatal outcome: Congenital anomalies | From birth up to 28 days post-birth | Incidence rates of congenital anomalies (major and minor) in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse neonatal outcome: Neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia | From birth up to 28 days post-birth | Incidence rates of neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse fetal outcome: Fetal growth arrest (restriction) | From 1st day of the 27th week of gestation up to 42 weeks gestation | Incidence rates of fetal growth arrest (restriction) in Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse outcomes in pregnant individuals: Preterm labor | From 1st day of the 27th week of gestation and less than 37 weeks gestation | Incidence rates of Preterm labor in Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse outcomes in pregnant individuals: Preeclampsia/eclampsia | From 1st day of the 27th week of gestation up to 42 days postpartum | Incidence rates of preeclampsia/eclampsia in Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse outcomes in pregnant individuals: Postpartum hemorrhage | Within 24 hours of delivery up to 28 days postpartum | Incidence rates of postpartum hemorrhage in Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse outcomes in pregnant individuals: Placental abruption | From 1st day of the 27th week of gestation up to 42 weeks gestation | Incidence rates of placental abruption in Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse outcomes in pregnant individuals: Premature rupture of membranes | From 1st day of the 27th week of gestation up to 42 weeks gestation | Incidence rates of premature rupture of membranes in Adacel-exposed and Tdap-unvaccinated comparator cohorts |
| Adverse outcomes in pregnant individuals: Chorioamnionitis | From 1st day of the 27th week of gestation up to 42 weeks gestation | Incidence rates of chorioamnionitis in Adacel-exposed and Tdap-unvaccinated comparator cohorts |
Countries
France
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed