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

NCT06258057 | Active Not Recruiting FDA Drug

• 2 other identifiers: TD500066U1111-1290-9165
• Study Type: observational
• Target: 365,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pertussis (Whooping Cough)

Outcome Measures

Primary Outcomes (6)

• Pregnancy outcome: Live birth

  Incidence rates of live births in Adacel-exposed and Tdap-unvaccinated comparator cohorts

  From 1st day of the 27th week of gestation up to 42 weeks gestation

• Pregnancy outcome: Still birth/fetal demise

  Incidence rates of still birth/fetal demise in Adacel-exposed and Tdap-unvaccinated comparator cohorts

  From 1st day of the 27th week of gestation up to 42 weeks gestation

• Pregnancy outcome: Therapeutic abortion

  Incidence rates of therapeutic abortion in Adacel-exposed and Tdap-unvaccinated comparator cohorts

  From 1st day of the 27th week of gestation up to 42 weeks gestation

• Birth outcome: Preterm birth

  Incidence rates of preterm birth in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts

  From 1st day of the 27th week of gestation and less than 37 weeks gestation

• Birth outcome: Low birth weight

  Incidence rates of low birth weight in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts

  From 1st day of the 27th week of gestation up to 42 weeks gestation

• Birth outcome: Small for gestational age

  Incidence rates of small for gestational age in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts

  From 1st day of the 27th week of gestation up to 42 weeks gestation

Secondary Outcomes (12)

• 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 neonatal outcome: Neonatal respiratory distress

  From birth up to 28 days post-birth

• Adverse neonatal outcome: Congenital anomalies

  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

Study Arms (2)

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

Other: Not applicable / database analysis

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

Other: Not applicable / database analysis

Interventions

Not applicable / database analysis OTHER

Not applicable / database analysis

Adacel-Exposed Cohort; Tdap-Unvaccinated Comparator Cohort

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Pregnant individuals and their offspring
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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:
• With gestational age as calculated based on date of birth recorded in the EMR

You may not qualify if:

• 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:

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site

Chilly-Mazarin, 91380, France

Location

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 14, 2024
• Study Start: January 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)