Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-27 @ 4:43 AM
Study NCT ID:
NCT06258057
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014917', 'term': 'Whooping Cough'}], 'ancestors': [{'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 365000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy outcome: Live birth', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 weeks gestation', 'description': 'Incidence rates of live births in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Pregnancy outcome: Still birth/fetal demise', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 weeks gestation', 'description': 'Incidence rates of still birth/fetal demise in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Pregnancy outcome: Therapeutic abortion', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 weeks gestation', 'description': 'Incidence rates of therapeutic abortion in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Birth outcome: Preterm birth', 'timeFrame': 'From 1st day of the 27th week of gestation and less than 37 weeks gestation', 'description': 'Incidence rates of preterm birth in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Birth outcome: Low birth weight', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 weeks gestation', 'description': 'Incidence rates of low birth weight in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Birth outcome: Small for gestational age', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 weeks gestation', 'description': 'Incidence rates of small for gestational age in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts'}], 'secondaryOutcomes': [{'measure': 'Adverse neonatal outcome: Neonatal death', 'timeFrame': 'From birth up to 28 days post-birth', 'description': 'Incidence rates of neonatal death in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse neonatal outcome: Neonatal sepsis', 'timeFrame': 'From birth up to 28 days post-birth', 'description': 'Incidence rates of neonatal sepsis in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse neonatal outcome: Neonatal respiratory distress', 'timeFrame': 'From birth up to 28 days post-birth', 'description': 'Incidence rates of neonatal respiratory distress in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse neonatal outcome: Congenital anomalies', 'timeFrame': 'From birth up to 28 days post-birth', 'description': 'Incidence rates of congenital anomalies (major and minor) in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse neonatal outcome: Neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia', 'timeFrame': 'From birth up to 28 days post-birth', 'description': 'Incidence rates of neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse fetal outcome: Fetal growth arrest (restriction)', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 weeks gestation', 'description': 'Incidence rates of fetal growth arrest (restriction) in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse outcomes in pregnant individuals: Preterm labor', 'timeFrame': 'From 1st day of the 27th week of gestation and less than 37 weeks gestation', 'description': 'Incidence rates of Preterm labor in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse outcomes in pregnant individuals: Preeclampsia/eclampsia', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 days postpartum', 'description': 'Incidence rates of preeclampsia/eclampsia in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse outcomes in pregnant individuals: Postpartum hemorrhage', 'timeFrame': 'Within 24 hours of delivery up to 28 days postpartum', 'description': 'Incidence rates of postpartum hemorrhage in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse outcomes in pregnant individuals: Placental abruption', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 weeks gestation', 'description': 'Incidence rates of placental abruption in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'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', 'description': 'Incidence rates of premature rupture of membranes in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}, {'measure': 'Adverse outcomes in pregnant individuals: Chorioamnionitis', 'timeFrame': 'From 1st day of the 27th week of gestation up to 42 weeks gestation', 'description': 'Incidence rates of chorioamnionitis in Adacel-exposed and Tdap-unvaccinated comparator cohorts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pertussis (Whooping Cough)']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nThe 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.', 'detailedDescription': 'Study outcomes to be assessed in electronic medical records between January 2016 to December 2025.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'genderDescription': 'Pregnant individuals and their offspring', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For pregnant individuals:\n\n * Continuous enrollment, with no more than a 1-month administrative gap from 90 days prior to their last menstrual period (LMP)\n * 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\n * At least 1 prenatal visit prior to 27 weeks of gestation during pregnancy\n* For offspring:\n\n * Infants delivered by pregnant individuals who meet all the inclusion criteria above\n * With gestational age as calculated based on date of birth recorded in the EMR\n\nExclusion Criteria:\n\n* For pregnant individuals:\n\n * Loss of pregnancy or with delivery before 27 weeks of gestation\n * Vaccinated with Boostrix® (Tdap vaccine, GSK), or with an unknown brand of Tdap vaccine, or Td (tetanus, diphtheria) vaccine during pregnancy\n * Vaccinated with any Tdap vaccine prior to the ACIP recommended optimal timeframe of ≥ 270/7 weeks of gestation\n * Received more than one Tdap vaccine during pregnancy\n * Vaccinated with one or more live vaccines during pregnancy\n * Pregnant individuals with multiple gestation pregnancies (eg, twins, triplets)\n* For offspring:\n\n * Infants delivered by pregnant individuals who meet any of the exclusion criteria above'}, 'identificationModule': {'nctId': 'NCT06258057', 'briefTitle': 'Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy: A Cohort Study Using US Electronic Medical Record Data', 'orgStudyIdInfo': {'id': 'TD500066'}, 'secondaryIdInfos': [{'id': 'U1111-1290-9165', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': 'TD500066', 'type': 'OTHER', 'domain': 'Sanofi Identifier'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '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', 'interventionNames': ['Other: Not applicable / database analysis']}, {'label': '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', 'interventionNames': ['Other: Not applicable / database analysis']}], 'interventions': [{'name': 'Not applicable / database analysis', 'type': 'OTHER', 'description': 'Not applicable / database analysis', 'armGroupLabels': ['Adacel-Exposed Cohort', 'Tdap-Unvaccinated Comparator Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91380', 'city': 'Chilly-Mazarin', 'country': 'France', 'facility': 'Investigational Site', 'geoPoint': {'lat': 48.71489, 'lon': 2.31638}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "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"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}