Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
NCT ID: NCT06258057
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
365000 participants
OBSERVATIONAL
2024-01-02
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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
Not applicable / database analysis
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
Not applicable / database analysis
Not applicable / database analysis
Interventions
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Not applicable / database analysis
Not applicable / database analysis
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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:
15 Years
49 Years
FEMALE
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site
Chilly-Mazarin, , France
Countries
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Other Identifiers
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U1111-1290-9165
Identifier Type: REGISTRY
Identifier Source: secondary_id
TD500066
Identifier Type: OTHER
Identifier Source: secondary_id
TD500066
Identifier Type: -
Identifier Source: org_study_id
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