Clinical trial NCT06258057: Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
Official title: Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy: A Cohort Study Using US Electronic Medical Record Data
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pertussis (Whooping Cough)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 365000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be comprised of 2 cohorts of pregnant individuals with pregnancy onset from 01 January 2016 through 31 December 2024. Infants born from this study population of pregnant individuals with singleton gestation pregnancies will be eligible for inclusion in this study. Eligible live born infants must be born on 01 October 2025 or prior to this date, to allow adequate follow-up time

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: Study outcomes to be assessed in electronic medical records between January 2016 to December 2025.

Eligibility criteria: 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 ≥ 270/7 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 outcomes:
measure: Pregnancy outcome: Live birth
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
measure: Pregnancy outcome: Still birth/fetal demise
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
measure: Pregnancy outcome: Therapeutic abortion
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
measure: Birth outcome: Preterm birth
timeFrame: From 1st day of the 27th week of gestation and less than 37 weeks gestation
measure: Birth outcome: Low birth weight
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
measure: Birth outcome: Small for gestational age
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Secondary outcomes:
measure: Adverse neonatal outcome: Neonatal death
timeFrame: From birth up to 28 days post-birth
measure: Adverse neonatal outcome: Neonatal sepsis
timeFrame: From birth up to 28 days post-birth
measure: Adverse neonatal outcome: Neonatal respiratory distress
timeFrame: From birth up to 28 days post-birth
measure: Adverse neonatal outcome: Congenital anomalies
timeFrame: From birth up to 28 days post-birth
measure: Adverse neonatal outcome: Neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia
timeFrame: From birth up to 28 days post-birth
measure: Adverse fetal outcome: Fetal growth arrest (restriction)
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
measure: Adverse outcomes in pregnant individuals: Preterm labor
timeFrame: From 1st day of the 27th week of gestation and less than 37 weeks gestation
measure: Adverse outcomes in pregnant individuals: Preeclampsia/eclampsia
timeFrame: From 1st day of the 27th week of gestation up to 42 days postpartum
measure: Adverse outcomes in pregnant individuals: Postpartum hemorrhage
timeFrame: Within 24 hours of delivery up to 28 days postpartum
measure: Adverse outcomes in pregnant individuals: Placental abruption
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
measure: Adverse outcomes in pregnant individuals: Premature rupture of membranes
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
measure: Adverse outcomes in pregnant individuals: Chorioamnionitis
timeFrame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Other outcomes:
Locations:
city: Chilly-Mazarin
country: France
facility: Investigational Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: