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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-9165 | Registry Identifier | ICTRP | |
| TD500066 | Other Identifier | Sanofi Identifier |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable / database analysis | Other | Not applicable / database analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse neonatal outcome: Neonatal death | Incidence rates of neonatal death in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts | From birth up to 28 days post-birth |
| Adverse neonatal outcome: Neonatal sepsis |
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Inclusion Criteria:
For pregnant individuals:
For offspring:
Exclusion Criteria:
For pregnant individuals:
For offspring:
Pregnant individuals and their offspring
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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Chilly-Mazarin | 91380 | France |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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Incidence rates of neonatal sepsis in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts
| From birth up to 28 days post-birth |
| Adverse neonatal outcome: Neonatal respiratory distress | Incidence rates of neonatal respiratory distress in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts | From birth up to 28 days post-birth |
| Adverse neonatal outcome: Congenital anomalies | Incidence rates of congenital anomalies (major and minor) in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts | From birth up to 28 days post-birth |
| Adverse neonatal outcome: Neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia | Incidence rates of neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts | From birth up to 28 days post-birth |
| Adverse fetal outcome: Fetal growth arrest (restriction) | Incidence rates of fetal growth arrest (restriction) in Adacel-exposed and Tdap-unvaccinated comparator cohorts | From 1st day of the 27th week of gestation up to 42 weeks gestation |
| Adverse outcomes in pregnant individuals: Preterm labor | Incidence rates of Preterm labor in Adacel-exposed and Tdap-unvaccinated comparator cohorts | From 1st day of the 27th week of gestation and less than 37 weeks gestation |
| Adverse outcomes in pregnant individuals: Preeclampsia/eclampsia | Incidence rates of preeclampsia/eclampsia in Adacel-exposed and Tdap-unvaccinated comparator cohorts | From 1st day of the 27th week of gestation up to 42 days postpartum |
| Adverse outcomes in pregnant individuals: Postpartum hemorrhage | Incidence rates of postpartum hemorrhage in Adacel-exposed and Tdap-unvaccinated comparator cohorts | Within 24 hours of delivery up to 28 days postpartum |
| Adverse outcomes in pregnant individuals: Placental abruption | Incidence rates of placental abruption in Adacel-exposed and Tdap-unvaccinated comparator cohorts | From 1st day of the 27th week of gestation up to 42 weeks gestation |
| Adverse outcomes in pregnant individuals: Premature rupture of membranes | Incidence rates of premature rupture of membranes in Adacel-exposed and Tdap-unvaccinated comparator cohorts | From 1st day of the 27th week of gestation up to 42 weeks gestation |
| Adverse outcomes in pregnant individuals: Chorioamnionitis | Incidence rates of chorioamnionitis in Adacel-exposed and Tdap-unvaccinated comparator cohorts | From 1st day of the 27th week of gestation up to 42 weeks gestation |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |