PertussisTdapNCT02209623
TDAP Safety in Pregnant Women
An observational study of Pertussis, run by Vanderbilt University at 2 sites in United States.
Trial summary
The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0 days gestation receiving Tdap as part of standard practice. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- TDAP
- How many people
- 375 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to 18 Dec 2017
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 375 healthy pregnant women at ≥ 20 weeks 0 days gestation through ≤ 34 weeks 0 days gestation and their infants and 225 healthy non-pregnant women, age range 18-45 years
Who may be able to join
- Subjects who meet the following criteria will be eligible to participate in this observational study. Tdap administration will be given as routine standard of care.
- Pregnant and non-pregnant women, as determined by medical history, aged 18 - 45 years of age inclusive
- For pregnant women only - Singleton gestation ≥ 20 weeks 0 days gestation - ≤34 weeks 0 days gestation based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA) - EDD will be based on reconciliation of a "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
- Intention of receiving Tdap vaccine based on ACIP guidelines
- Willing to provide written informed consent prior to initiation of any study procedures
- English or Spanish literate
- Intention of being available for entire study period and complete all relevant study procedures
Who cannot join
- Subjects who meet the following criteria will not be eligible to participate in this study:
- Febrile illness within the last 24 hours or an oral temperature > 100.4oF (> 38oC) prior to Tdap administration
- Severe allergic reaction (e.g., anaphylaxis) to any component of Tdap or any other diphtheria toxoid, tetanus toxoid and pertussis antigen containing vaccine
- Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine.
- Known or suspected impairment of immunologic function including active infection with HIV, hepatitis B or C, current use of glucocorticoids, i.e., oral, parenteral, and high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs.
- Note, if a woman were to require antenatal corticosteroids for benefit of fetal lung maturity within 8 days post enrollment, she would not be excluded from the study for reactogenicity analysis. However, if antenatal corticosteroids were received anytime between vaccination and 28-day sample collection for serologic studies, she would be excluded from serologic studies as they could be altered by steroid receipt.
Show all 17Show fewer
- Receipt of any licensed vaccine OR investigational product within 1 week prior to Tdap vaccination in this study or planning receipt of any vaccines during 8-day post-vaccination period.
- Note, any woman receiving an investigational vaccine or live vaccine inadvertently at any time during pregnancy will be excluded from analysis. (Note, inadvertent receipt of licensed HPV vaccine or any other inactivated licensed vaccine outside of the parameters specified above is not a reason for exclusion).
- Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
- Anyone who is a relative of any research study personnel
- Anyone who is an employee of any research study personnel
- For pregnant women only
- Tdap/Td/TT receipt during current pregnancy prior to study enrollment
- Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change
- For non-pregnant women only
- Intention of becoming pregnant during study participation
- Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product within 30 days of Tdap receipt. Co-enrollment in observational or behavioral intervention studies are allowed at any time while enrollment in a clinical trial involving an investigational product (other than vaccine) may occur after 30 days following Tdap receipt. Receipt of inactivated vaccines during pregnancy, including routinely recommended inactivated influenza vaccine, given as part of usual care, is not an exclusion for this study, except during the 8 days after Tdap vaccination
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Dept of ObGyn, Division of Maternal-Fetal Medicine
Durham, North Carolina, 27705
Vanderbilt Medical Center, Vaccine Research Program
Nashville, Tennessee, 37232
About this study
Official title: Clinical Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) Safety in Pregnant Women
The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0 days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be verified by medical record review when possible. There will be an emphasis on enrolling women who have received Tdap before the current pregnancy, to the greatest extent possible. Non-pregnant women who are receiving their initial Tdap will also be recruited.
Injection-site (local) and systemic reaction data will be assessed on the vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on the preference of the study participant.
Pregnant women will be followed until delivery with comprehensive obstetric and neonatal outcomes obtained from review of the electronic medical record.
Read the detailed description
This is an observational study of both pregnant and non-pregnant women. Vaccine administration in the pregnant population will be part of routine care. Vaccine administration in the non-pregnant women will be provided as either routine care or as part of the study. Pregnant women at ≥ 20 weeks 0 days gestation who have not received Tdap during the current pregnancy will be enrolled, with prioritized emphasis on enrolling pregnant women who have received Tdap prior to the current pregnancy in order to attempt to address the question of closely-spaced repeated dosing. Detailed data will be collected from study participants on prior Tdap/Td/TT receipt. The non-pregnant women will consist of both Tdap naïve and those who have received Tdap previously. With Day 0 serving as the day of vaccination, participants will be followed through Day 7 for symptoms of reactogenicity. For Primary Objective 1, symptoms of reactogenicity occurring from Day 0 -7 will be compared between pregnant and non-pregnant women. For Objective 2, pregnant women will be followed through delivery for collection of pregnancy outcome data. Pregnancy outcomes among study participants will be compared with historical outcomes from summary data from both Vanderbilt and Duke. In addition, follow-up will be conducted for infants born to mothers who received Tdap during pregnancy to assess health outcomes and growth parameters through 6 months of life.
- Conditions
- Pertussis
- Being tested
- TDAP
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDAPBiological
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women receiving TDAP | Not described Receives: Biological: TDAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of injection-site and systemic reactions post Tdap administration.
Rates of injection-site and systemic reactions after Tdap in pregnant women versus non-pregnant women will be compared.
Measured: 7 days post administration
Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally
Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally will be evaluated by review of the hospital delivery record following delivery.
Measured: 7 days post delivery
Secondary outcomes (3)
Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose
Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose will be explored.
Measured: 7 days post vaccination
Rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap
To assess rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap including, but not limited to, maternal or fetal death, placental abruption, postpartum hemorrhage, pregnancy related hypertension, gestational diabetes
Measured: 7 days post delivery
Health outcomes and growth parameters among infants born to women who received Tdap during pregnancy
To describe health outcomes and growth parameters through 6 months of life among infants born to women who received Tdap during pregnancy
Measured: 6 months post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Kathryn Edwards, Vanderbilt University
- Investigators
- Kathryn M Edwards, MD, Principal investigator, Vanderbilt Medical CenterGeeta K Swamy, MD, Principal investigator, Duke Medical CenterKaren R Broder, MD, Principal investigator, Centers for Disease Control and PreventionKimberly B Fortner, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209623
- Sponsor's protocol ID
- CISA 2014 Task III
- Acronym
- Tdap
- Status last verified
- Dec 2017
- First submitted
- 28 Jul 2014
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fortner KB, Swamy GK, Broder KR, Jimenez-Truque N, Zhu Y, Moro PL, Liang J, Walter EB, Heine RP, Moody MA, Yoder S, Edwards KM. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine. 2018 Oct 8;36(42):6354-6360. doi: 10.1016/j.vaccine.2018.07.012. Epub 2018 Sep 13.
PubMed 30219367
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) Safety in Pregnant Women
- ClinicalTrials.gov ID
- NCT02209623
- Acronym / sponsor ID
- Tdap / CISA 2014 Task III
- Conditions
- Pertussis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Duke University, Centers for Disease Control and Prevention
- Study start
- May 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 6 Aug 2014 (estimated)
- 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 observational study is to evaluate the safety of Tetanus Toxoid Reduced Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0 days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be verified by medical record review when possible. There will be an emphasis on enrolling women who have received Tdap before the current pregnancy, to the greatest extent possible. Non-pregnant women who are receiving their initial Tdap will also be recruited.
Injection-site (local) and systemic reaction data will be assessed on the vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on the preference of the study participant.
Pregnant women will be followed until delivery with comprehensive obstetric and neonatal outcomes obtained from review of the electronic medical record.
Detailed description
This is an observational study of both pregnant and non-pregnant women. Vaccine administration in the pregnant population will be part of routine care. Vaccine administration in the non-pregnant women will be provided as either routine care or as part of the study. Pregnant women at ≥ 20 weeks 0 days gestation who have not received Tdap during the current pregnancy will be enrolled, with prioritized emphasis on enrolling pregnant women who have received Tdap prior to the current pregnancy in order to attempt to address the question of closely-spaced repeated dosing. Detailed data will be collected from study participants on prior Tdap/Td/TT receipt. The non-pregnant women will consist of both Tdap naïve and those who have received Tdap previously. With Day 0 serving as the day of vaccination, participants will be followed through Day 7 for symptoms of reactogenicity. For Primary Objective 1, symptoms of reactogenicity occurring from Day 0 -7 will be compared between pregnant and non-pregnant women. For Objective 2, pregnant women will be followed through delivery for collection of pregnancy outcome data. Pregnancy outcomes among study participants will be compared with historical outcomes from summary data from both Vanderbilt and Duke. In addition, follow-up will be conducted for infants born to mothers who received Tdap during pregnancy to assess health outcomes and growth parameters through 6 months of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women receiving TDAP | – | Biological: TDAP |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 375 healthy pregnant women at ≥ 20 weeks 0 days gestation through ≤ 34 weeks 0 days gestation and their infants and 225 healthy non-pregnant women, age range 18-45 years
Key inclusion criteria (7 listed)
- Subjects who meet the following criteria will be eligible to participate in this observational study. Tdap administration will be given as routine standard of care.
- Pregnant and non-pregnant women, as determined by medical history, aged 18 - 45 years of age inclusive
- For pregnant women only - Singleton gestation ≥ 20 weeks 0 days gestation - ≤34 weeks 0 days gestation based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA) - EDD will be based on reconciliation of a "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
- Intention of receiving Tdap vaccine based on ACIP guidelines
- Willing to provide written informed consent prior to initiation of any study procedures
Key exclusion criteria (17 listed)
- Subjects who meet the following criteria will not be eligible to participate in this study:
- Febrile illness within the last 24 hours or an oral temperature > 100.4oF (> 38oC) prior to Tdap administration
- Severe allergic reaction (e.g., anaphylaxis) to any component of Tdap or any other diphtheria toxoid, tetanus toxoid and pertussis antigen containing vaccine
- Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine.
- Known or suspected impairment of immunologic function including active infection with HIV, hepatitis B or C, current use of glucocorticoids, i.e., oral, parenteral, and high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs.
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 |
|---|---|---|
| TDAP | Biological | Pregnant Women receiving TDAP |
Primary outcome
Rates of injection-site and systemic reactions post Tdap administration.
Time frame: 7 days post administration
Rates of injection-site and systemic reactions after Tdap in pregnant women versus non-pregnant women will be compared.
Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally
Time frame: 7 days post delivery
Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally will be evaluated by review of the hospital delivery record following delivery.
3 secondary outcomes
Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose
Time frame: 7 days post vaccination
Rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap
Time frame: 7 days post delivery
Health outcomes and growth parameters among infants born to women who received Tdap during pregnancy
Time frame: 6 months post delivery
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 20 Dec 2017.
- Derived from this study: PubMed 30219367Fortner KB, Swamy GK, Broder KR, Jimenez-Truque N, Zhu Y, Moro PL, Liang J, Walter EB, Heine RP, Moody MA, Yoder S, Edwards KM. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine. 2018 Oct 8;36(42):6354-6360. doi: 10.1016/j.vaccine.2018.07.012. Epub 2018 Sep 13.
- Individual participant dataSharing planned: No
Related trials for Pertussis
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A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
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.
Kathryn M Edwards, MD principal investigator
Vanderbilt Medical Center
Geeta K Swamy, MD principal investigator
Duke Medical Center
Karen R Broder, MD principal investigator
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis, run by Vanderbilt University at 2 sites in United States.
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 17 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 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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?
Rates of injection-site and systemic reactions post Tdap administration. (time frame: 7 days post administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02209623, which also lists 1 linked publication.
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 20 Dec 2017.