Pertussis VaccinesNCT07735767
Tdap Vaccination During Pregnancy or Postpartum and Lactation-Related Outcomes
An observational study of Pertussis Vaccines, run by HealthPartners Institute.
Trial summary
A retrospective cohort study based on the secondary use of pre-existing data. The study assesses the association between antenatal and postpartum maternal Tdap vaccination and select infant and lactation-related outcomes. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis Vaccines
- What is being tested?
- Tetanus Toxoid, acellular pertussis, diphtheria toxoid
- Type of treatment
- Vaccines
- How many people
- 36,245 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Retrospective cohort study using existing automated electronic health record (EHR) data from two large integrated health care delivery systems based in Hawaii (Kaiser Permanente Hawaii) and Minnesota (HealthPartners).
Who may be able to join
- The study includes pregnant women aged 16-49 years at delivery who had a live-birth delivery between 01 January 2014 (01 June 2018 for one site given data availability) and 31 December 2022, received prenatal care within the participating health systems before 6 months gestation, had a gestational age at delivery of at least 27 weeks, and linked to an infant with a WCV before 2 months of age within the participating health systems.
Who cannot join
- We excluded those with Tdap vaccination before the recommended gestational age of 27 gestational weeks. For postpartum analyses, we excluded those who did not initiate human milk feeding or where human milk feeding information was not available.
About this study
A retrospective cohort study based on the secondary use of pre-existing data. The study assesses the association between antenatal and postpartum maternal Tdap vaccination and select infant and lactation-related outcomes.
Read the detailed description
Since 2012, the United States Advisory Committee on Immunization Practices has recommended administering the Tdap (tetanus, diphtheria, acellular pertussis) vaccine during every pregnancy, ideally between 27 and 36 gestational weeks, to reduce pertussis morbidity and mortality in young infants. Although the safety of Tdap during pregnancy for maternal and birth outcomes is well-documented, there are very limited data on lactation-related outcomes following Tdap vaccination.
This is a novel study of antenatal and postpartum Tdap vaccination and select adverse infant and lactation-related outcomes in mother-infant pairs to address the need for comprehensive safety data. Study specific aims:
Aim 1: To assess associations between receipt of Tdap vaccine in pregnancy and the risk of adverse infant and lactation-related outcomes.
Aim 2: To assess associations between receipt of Tdap vaccine postpartum and the risk of adverse infant and lactation-related outcomes among women who are breastfeeding in the 3 months postpartum.
No investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Tdap vaccine as part of routine care.
- Conditions
- Pertussis Vaccines
- Being tested
- Tetanus Toxoid, acellular pertussis, diphtheria toxoid
- Keywords
- Tdap, Pregnancy, Postpartum, Lactation, Infant, Electronic Health Record, Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus Toxoid, acellular pertussis, diphtheria toxoidBiological
No investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Tdap vaccine as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Group | Patients who received Tdap vaccine during pregnancy or up to 90 days postpartum. Receives: Biological: Tetanus Toxoid, acellular pertussis, diphtheria toxoid | |
| Unvaccinated Control Group | Patients who did not receive Tdap vaccine during pregnancy and/or up to 90 days postpartum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant growth - failure to thrive (Subgroup Pregnancy)
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy and up to 90 days after delivery
Measured: 3 months (91 days) to 12 months of age
Infant growth - failure to thrive (Subgroup Postpartum)
Among patients who did not discontinue human milk feeding on or before 90 days after delivery.
Exposure: Any Tdap 0 to 90 days after delivery
Comparator: No Tdap 0 to 90 days after delivery
Measured: 3 months (91 days) to 12 months of age
Infant health care utilization - Number of infant outpatient visits up to 6 months of age (Subgroup Pregnancy)
Count of unique dates of outpatient visits in the 6 months after delivery.
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy and up to 90 days after delivery
Measured: 0 to 6 months after delivery
Infant health care utilization - Number of infant outpatient visits in the 90 days after index date (Subgroup Postpartum )
Among patients who did not discontinue human milk feeding before index date (ie, vaccination or pseudovaccination date), count of unique dates of outpatient visits in the 90 days after vaccination or pseudovaccination.
Exposure: Any Tdap 0 to 90 days after delivery
Comparator: No Tdap 0 to 90 days after delivery
Measured: up to 6 months: 90-day window for vaccination plus 90-day window for outcome assessment
Infant health care utilization - Number of infant emergency department visits up to 6 months of age (Subgroup Pregnancy)
Count of unique dates of emergency department visits in the 6 months after delivery.
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy and up to 90 days after delivery
Measured: 0 to 6 months after delivery
Infant health care utilization - Number of infant emergency department visits in 90 days after index date (Subgroup Postpartum)
Among patients who did not discontinue human milk feeding before index date (ie, vaccination or pseudovaccination date), count of unique dates of emergency department visits in the 90 days after vaccination or pseudovaccination.
Exposure: Any Tdap 0 to 90 days after delivery
Comparator: No Tdap 0 to 90 days after delivery
Measured: Up to 6 months: 90-day window for vaccination plus 90-day window for outcome assessment.
Human milk feeding initiation vs no initiation (Subgroup Pregnancy)
Any or exclusive human milk versus formula only or no human milk feeding documented during follow up.
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy
Measured: 0 to 12 months
Any human milk feeding vs none around the 2-month Well Child Visit (WCV) (Subgroup Pregnancy)
Any human milk versus formula only or no human milk feeding documented 42 to 104 days after delivery
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy through 41 days after delivery
Measured: 42 to 104 days after delivery
Any human milk feeding vs none around the 2-month WCV (Subgroup Postpartum)
Among those patients who did not discontinue human milk feeding before Tdap vaccine receipt or before the outcome window of interest, any human milk versus formula only or no human milk feeding documented 42 to 104 days after delivery
Exposure: Any Tdap 0 to 41 days after delivery
Comparator: No Tdap during pregnancy through 41 days after delivery
Measured: 42 to 104 days after delivery
Exclusive human milk feeding vs none around the 2-month WCV (Subgroup Pregnancy)
Exclusive human milk feeding only versus formula, with or without human milk documented 42 to 104 days after delivery
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy through 41 days after delivery
Measured: 42 to 104 days after delivery
Exclusive human milk feeding vs none around the 2-month WCV (Subgroup Postpartum)
Among those patients who did not discontinue human milk feeding before Tdap vaccine receipt or before the outcome window of interest, exclusive human milk feeding only versus formula, with or without human milk documented 42 to 104 days after delivery
Exposure: Any Tdap 0 to 41 days after delivery Comparator: No Tdap during pregnancy through 41 days after delivery
Measured: 42 to 104 days after delivery
Any human milk feeding vs none around the 6-month WCV (Subgroup Pregnancy)
Any human milk versus formula only or no human milk feeding documented 148 to 210 days after delivery
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy through 147 days after delivery
Measured: 148 to 210 days after delivery
Any human milk feeding vs none around the 6-month WCV (Subgroup Postpartum)
Among those patients who did not discontinue human milk feeding before Tdap vaccine receipt or before the outcome window of interest, any human milk versus formula only or no human milk feeding documented 148 to 210 days after delivery
Exposure: Any Tdap 0 to 90 days after delivery
Comparator: No Tdap 0 to 90 days after delivery
Measured: 148 to 210 days after delivery
Exclusive human milk feeding vs none around the 6-month WCV (Subgroup Pregnancy)
Exclusive human milk feeding only versus formula, with or without human milk documented 148 to 210 days after delivery
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy through 147 days after delivery
Measured: 148 to 210 days after delivery
Exclusive human milk feeding vs none around the 6-month WCV (Subgroup Postpartum)
Among those patients who did not discontinue human milk feeding before Tdap vaccine receipt or before the outcome window of interest, exclusive human milk feeding only versus formula, with or without human milk documented 148 to 210 days after delivery
Exposure: Any Tdap 0 to 90 days after delivery
Comparator: No Tdap 0 to 90 days after delivery
Measured: 148 to 210 days after delivery
Secondary outcomes (2)
Infant growth - Rate of weight gain (Subgroup Pregnancy)
Average predicted rate of weight gained (kg/month) between 3 and 9 months < 5th percentile for sex in the study population vs ≥ 5th percentile
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date
Comparator: No Tdap during pregnancy and up to 90 days after delivery
Measured: 3 - 9 months (To determine predicted values at 9 months of age, measurements up to 12 months were used)
Infant growth - Rate of weight gain (Subgroup Postpartum)
Among those patients who not discontinue human milk feeding on or before 90 days after delivery, average predicted rate of weight gained (kg/month) between 3 and 9 months < 5th percentile for sex in the study population vs ≥ 5th percentile
Exposure: Any Tdap 0 to 90 days after delivery
Comparator: No Tdap 0 to 90 days after delivery
Measured: 3 - 9 months (To determine predicted values at 9 months of age, measurements up to 12 months were used)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startJan 2014
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis VaccinesStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 36,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Kaiser Permanente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735767
- Sponsor's protocol ID
- Td500060
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tdap Vaccination During Pregnancy or Postpartum and Lactation-Related Outcomes
- ClinicalTrials.gov ID
- NCT07735767
- Acronym / sponsor ID
- Td500060
- Conditions
- Pertussis Vaccines
- Keywords
- Tdap, Pregnancy, Postpartum, Lactation, Infant, Electronic Health Record, Breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,245 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Sanofi, Kaiser Permanente
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 30 Jul 2026 (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.
A retrospective cohort study based on the secondary use of pre-existing data. The study assesses the association between antenatal and postpartum maternal Tdap vaccination and select infant and lactation-related outcomes.
Detailed description
Since 2012, the United States Advisory Committee on Immunization Practices has recommended administering the Tdap (tetanus, diphtheria, acellular pertussis) vaccine during every pregnancy, ideally between 27 and 36 gestational weeks, to reduce pertussis morbidity and mortality in young infants. Although the safety of Tdap during pregnancy for maternal and birth outcomes is well-documented, there are very limited data on lactation-related outcomes following Tdap vaccination.
This is a novel study of antenatal and postpartum Tdap vaccination and select adverse infant and lactation-related outcomes in mother-infant pairs to address the need for comprehensive safety data. Study specific aims:
Aim 1: To assess associations between receipt of Tdap vaccine in pregnancy and the risk of adverse infant and lactation-related outcomes.
Aim 2: To assess associations between receipt of Tdap vaccine postpartum and the risk of adverse infant and lactation-related outcomes among women who are breastfeeding in the 3 months postpartum.
No investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Tdap vaccine as part of routine care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Group | – | Biological: Tetanus Toxoid, acellular pertussis, diphtheria toxoidPatients who received Tdap vaccine during pregnancy or up to 90 days postpartum. |
| Unvaccinated Control Group | – | –Patients who did not receive Tdap vaccine during pregnancy and/or up to 90 days postpartum. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Retrospective cohort study using existing automated electronic health record (EHR) data from two large integrated health care delivery systems based in Hawaii (Kaiser Permanente Hawaii) and Minnesota (HealthPartners).
Key inclusion criteria (1 listed)
- The study includes pregnant women aged 16-49 years at delivery who had a live-birth delivery between 01 January 2014 (01 June 2018 for one site given data availability) and 31 December 2022, received prenatal care within the participating health systems before 6 months gestation, had a gestational age at delivery of at least 27 weeks, and linked to an infant with a WCV before 2 months of age within the participating health systems.
Key exclusion criteria (1 listed)
- We excluded those with Tdap vaccination before the recommended gestational age of 27 gestational weeks. For postpartum analyses, we excluded those who did not initiate human milk feeding or where human milk feeding information was not available.
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 |
|---|---|---|
| Tetanus Toxoid, acellular pertussis, diphtheria toxoidNo investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Tdap vaccine as part of routine care. | Biological | Vaccine Group |
Primary outcome
Infant growth - failure to thrive (Subgroup Pregnancy)
Time frame: 3 months (91 days) to 12 months of age
Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date Comparator: No Tdap during pregnancy and up to 90 days after delivery
Infant growth - failure to thrive (Subgroup Postpartum)
Time frame: 3 months (91 days) to 12 months of age
Among patients who did not discontinue human milk feeding on or before 90 days after delivery. Exposure: Any Tdap 0 to 90 days after delivery Comparator: No Tdap 0 to 90 days after delivery
Infant health care utilization - Number of infant outpatient visits up to 6 months of age (Subgroup Pregnancy)
Time frame: 0 to 6 months after delivery
Count of unique dates of outpatient visits in the 6 months after delivery. Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date Comparator: No Tdap during pregnancy and up to 90 days after delivery
Infant health care utilization - Number of infant outpatient visits in the 90 days after index date (Subgroup Postpartum )
Time frame: up to 6 months: 90-day window for vaccination plus 90-day window for outcome assessment
Among patients who did not discontinue human milk feeding before index date (ie, vaccination or pseudovaccination date), count of unique dates of outpatient visits in the 90 days after vaccination or pseudovaccination. Exposure: Any Tdap 0 to 90 days after delivery Comparator: No Tdap 0 to 90 days after delivery
Infant health care utilization - Number of infant emergency department visits up to 6 months of age (Subgroup Pregnancy)
Time frame: 0 to 6 months after delivery
Count of unique dates of emergency department visits in the 6 months after delivery. Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date Comparator: No Tdap during pregnancy and up to 90 days after delivery
Infant health care utilization - Number of infant emergency department visits in 90 days after index date (Subgroup Postpartum)
Time frame: Up to 6 months: 90-day window for vaccination plus 90-day window for outcome assessment.
Among patients who did not discontinue human milk feeding before index date (ie, vaccination or pseudovaccination date), count of unique dates of emergency department visits in the 90 days after vaccination or pseudovaccination. Exposure: Any Tdap 0 to 90 days after delivery Comparator: No Tdap 0 to 90 days after delivery
Human milk feeding initiation vs no initiation (Subgroup Pregnancy)
Time frame: 0 to 12 months
Any or exclusive human milk versus formula only or no human milk feeding documented during follow up. Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date Comparator: No Tdap during pregnancy
Any human milk feeding vs none around the 2-month Well Child Visit (WCV) (Subgroup Pregnancy)
Time frame: 42 to 104 days after delivery
Any human milk versus formula only or no human milk feeding documented 42 to 104 days after delivery Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date Comparator: No Tdap during pregnancy through 41 days after delivery
Any human milk feeding vs none around the 2-month WCV (Subgroup Postpartum)
Time frame: 42 to 104 days after delivery
Among those patients who did not discontinue human milk feeding before Tdap vaccine receipt or before the outcome window of interest, any human milk versus formula only or no human milk feeding documented 42 to 104 days after delivery Exposure: Any Tdap 0 to 41 days after delivery Comparator: No Tdap during pregnancy through 41 days after delivery
Exclusive human milk feeding vs none around the 2-month WCV (Subgroup Pregnancy)
Time frame: 42 to 104 days after delivery
Exclusive human milk feeding only versus formula, with or without human milk documented 42 to 104 days after delivery Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date Comparator: No Tdap during pregnancy through 41 days after delivery
Exclusive human milk feeding vs none around the 2-month WCV (Subgroup Postpartum)
Time frame: 42 to 104 days after delivery
Among those patients who did not discontinue human milk feeding before Tdap vaccine receipt or before the outcome window of interest, exclusive human milk feeding only versus formula, with or without human milk documented 42 to 104 days after delivery Exposure: Any Tdap 0 to 41 days after delivery Comparator: No Tdap during pregnancy through 41 days after delivery
Any human milk feeding vs none around the 6-month WCV (Subgroup Pregnancy)
Time frame: 148 to 210 days after delivery
Any human milk versus formula only or no human milk feeding documented 148 to 210 days after delivery Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date Comparator: No Tdap during pregnancy through 147 days after delivery
Any human milk feeding vs none around the 6-month WCV (Subgroup Postpartum)
Time frame: 148 to 210 days after delivery
Among those patients who did not discontinue human milk feeding before Tdap vaccine receipt or before the outcome window of interest, any human milk versus formula only or no human milk feeding documented 148 to 210 days after delivery Exposure: Any Tdap 0 to 90 days after delivery Comparator: No Tdap 0 to 90 days after delivery
Exclusive human milk feeding vs none around the 6-month WCV (Subgroup Pregnancy)
Time frame: 148 to 210 days after delivery
Exclusive human milk feeding only versus formula, with or without human milk documented 148 to 210 days after delivery Exposure: Tdap on or after 27 gestational weeks (ie, > 188 days gestation) and less than delivery date Comparator: No Tdap during pregnancy through 147 days after delivery
Exclusive human milk feeding vs none around the 6-month WCV (Subgroup Postpartum)
Time frame: 148 to 210 days after delivery
Among those patients who did not discontinue human milk feeding before Tdap vaccine receipt or before the outcome window of interest, exclusive human milk feeding only versus formula, with or without human milk documented 148 to 210 days after delivery Exposure: Any Tdap 0 to 90 days after delivery Comparator: No Tdap 0 to 90 days after delivery
2 secondary outcomes
Infant growth - Rate of weight gain (Subgroup Pregnancy)
Time frame: 3 - 9 months (To determine predicted values at 9 months of age, measurements up to 12 months were used)
Infant growth - Rate of weight gain (Subgroup Postpartum)
Time frame: 3 - 9 months (To determine predicted values at 9 months of age, measurements up to 12 months were used)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis Vaccines, run by HealthPartners Institute.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Infant growth - failure to thrive (Subgroup Pregnancy) (time frame: 3 months (91 days) to 12 months of age). The study lists 15 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 30 Jul 2026.