Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy

Sanofi

Status: Active, not recruiting

Conditions: Pertussis (Whooping Cough)

Treatments: Other: Not applicable / database analysis

Study type: Observational

Funder types: Industry

Identifiers

NCT06258057

U1111-1290-9165 (Registry Identifier)

TD500066

Details and patient eligibility

About

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.

Full description

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

Enrollment: 365,000 estimated patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

365,000 participants in 2 patient groups

Adacel-Exposed Cohort

Description:

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

Treatment:

Other: Not applicable / database analysis

Tdap-Unvaccinated Comparator Cohort

Description:

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

Treatment:

Other: Not applicable / database analysis