Pertussis (Whooping Cough)NCT06258057
Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
An observational study of Pertussis (Whooping Cough), run by Sanofi at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis (Whooping Cough)
- What is being tested?
- Not applicable / database analysis
- Type of treatment
- Vaccines
- How many people
- 365,000 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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 ≥ 27 0/7 weeks of gestation
- Received more than one Tdap vaccine during pregnancy
- Vaccinated with one or more live vaccines during pregnancy
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy: A Cohort Study Using US Electronic Medical Record Data
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.
Read the detailed description
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.
- Conditions
- Pertussis (Whooping Cough)
- Being tested
- Not applicable / database analysis
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable / database analysisOther
Not applicable / database analysis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Not applicable / database analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcome: Live birth
Incidence rates of live births in Adacel-exposed and Tdap-unvaccinated comparator cohorts
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From 1st day of the 27th week of gestation up to 42 weeks gestation
Secondary outcomes (12)
Adverse neonatal outcome: Neonatal death
Incidence rates of neonatal death in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts
Measured: From birth up to 28 days post-birth
Adverse neonatal outcome: Neonatal sepsis
Incidence rates of neonatal sepsis in the offspring of Adacel-exposed and Tdap-unvaccinated comparator cohorts
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From 1st day of the 27th week of gestation up to 42 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start2 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis (Whooping Cough)Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 365,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258057
- Sponsor's protocol ID
- TD500066
- Other IDs
- U1111-1290-9165, TD500066
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy: A Cohort Study Using US Electronic Medical Record Data
- ClinicalTrials.gov ID
- NCT06258057
- Acronym / sponsor ID
- TD500066
- Conditions
- Pertussis (Whooping Cough)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 365,000 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adacel-Exposed Cohort | – | Other: Not applicable / database analysisCohort 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 |
| Tdap-Unvaccinated Comparator Cohort | – | Other: Not applicable / database analysisCohort 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 |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (7 listed)
- For pregnant individuals:
- For offspring:
Key exclusion criteria (9 listed)
- For pregnant individuals:
- For offspring:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable / database analysisNot applicable / database analysis | Other | Adacel-Exposed Cohort, Tdap-Unvaccinated Comparator Cohort |
Primary outcome
Pregnancy outcome: Live birth
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of live births in Adacel-exposed and Tdap-unvaccinated comparator cohorts
Pregnancy outcome: Still birth/fetal demise
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of still birth/fetal demise in Adacel-exposed and Tdap-unvaccinated comparator cohorts
Pregnancy outcome: Therapeutic abortion
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of therapeutic abortion in Adacel-exposed and Tdap-unvaccinated comparator cohorts
Birth outcome: Preterm birth
Time frame: From 1st day of the 27th week of gestation and less than 37 weeks gestation
Incidence rates of preterm birth in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts
Birth outcome: Low birth weight
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of low birth weight in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts
Birth outcome: Small for gestational age
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Incidence rates of small for gestational age in live born infants of both Adacel-exposed and Tdap-unvaccinated comparator cohorts
12 secondary outcomes
Adverse neonatal outcome: Neonatal death
Time frame: From birth up to 28 days post-birth
Adverse neonatal outcome: Neonatal sepsis
Time frame: From birth up to 28 days post-birth
Adverse neonatal outcome: Neonatal respiratory distress
Time frame: From birth up to 28 days post-birth
Adverse neonatal outcome: Congenital anomalies
Time frame: From birth up to 28 days post-birth
Adverse neonatal outcome: Neonatal/early infancy intensive care admissions for bronchopulmonary dysplasia
Time frame: From birth up to 28 days post-birth
Adverse fetal outcome: Fetal growth arrest (restriction)
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Adverse outcomes in pregnant individuals: Preterm labor
Time frame: From 1st day of the 27th week of gestation and less than 37 weeks gestation
Adverse outcomes in pregnant individuals: Preeclampsia/eclampsia
Time frame: From 1st day of the 27th week of gestation up to 42 days postpartum
Adverse outcomes in pregnant individuals: Postpartum hemorrhage
Time frame: Within 24 hours of delivery up to 28 days postpartum
Adverse outcomes in pregnant individuals: Placental abruption
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Adverse outcomes in pregnant individuals: Premature rupture of membranes
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Adverse outcomes in pregnant individuals: Chorioamnionitis
Time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis (Whooping Cough), run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcome: Live birth (time frame: From 1st day of the 27th week of gestation up to 42 weeks gestation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.