PregnancyPhase 4Tdap/IIVNCT02783170

Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women

A Phase 4 study testing Tetanus, Diphtheria, and Pertussis Vaccine, 2016-2017 Quadrivalent Inactivated Influenza Vaccine and 2017-2018 Quadrivalent Inactivated Influenza Vaccine in people with Pregnancy, run by Duke University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Pregnancy
What is being tested?: Tetanus, Diphtheria, and Pertussis Vaccine, 2016-2017 Quadrivalent Inactivated Influenza Vaccine and 2017-2018 Quadrivalent Inactivated Influenza Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 3 sitesUnited States
Study dates: Sep 2016to 10 May 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult

Who may be able to join

Pregnant, as determined by medical history; 18 - 45 years of age inclusive
Intention of receiving Tdap and IIV vaccines based on Advisory Committee on Immunization Practices (ACIP) recommendations
Willing to provide written informed consent prior to initiation of any study procedures
Singleton gestation ≥ 26 weeks 0 days gestation - ≤32 weeks 0 days gestation at the time of Visit 1 vaccination 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.
English or Spanish literate
Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information.

Who cannot join

For subjects enrolling during the 2016-2017 influenza season: IIV/LAIV receipt during 2016-2017 influenza season prior to study enrollment
For subjects enrolling during the 2017-2018 influenza season: IIV/LAIV receipt during 2017-2018 influenza season prior to study enrollment
2. Tdap/Td/TT receipt during current pregnancy prior to study enrollment 3. Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
4. Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants (daily low dose aspirin may be acceptable).
5. Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to enrollment in this study.
6. Known to have pre-existing diabetes mellitus or an autoimmune disorder. 7. Febrile illness within the last 24 hours or an oral temperature >/= 100.4°F (>/= 38.0°C) prior to IIV or Tdap administration 8. Contraindication to IIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component, including egg protein 9. Contraindication to Tdap receipt including history of severe allergic reaction after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause 10. Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine within the last 10 years 11. Any condition that may interfere with assessment of local injection site reactions, e.g. lymphadenectomy or obscuring tattoos 12. History of Guillain-Barré syndrome within 6 weeks of a prior dose of any tetanus toxoid-, diphtheria toxoid- or pertussis antigen-containing vaccine or influenza vaccine 13. Known or suspected impairment of immunologic function including infection with HIV, hepatitis B or C 14. Use of immunosuppressive or cytotoxic drugs except receipt of oral or parenteral (intravenous, subcutaneous or intramuscular) corticosteroids 30 or more days prior to enrollment. Persons who have used oral or parenteral corticosteroids within 12 months prior to enrollment may be enrolled if the longest course of therapy was less than 14 consecutive days and no dose was given within 30 days of enrollment. Intraarticular, bursal, tendon, or epidural injections of corticosteroids are permissible if the most recent injection was 30 or more days prior to enrolment. Persons applying topically corticosteroid in either upper arm (i.e. injection site) may be enrolled 1 or more days after their therapy is completed. Corticosteroids administered topically at non-injection sites, by inhalation or intranasally are permissible 15. Receipt of any licensed vaccine within 14 days prior to study vaccination or planning receipt of any vaccines (except study vaccines) prior to Visit 7 follow up.

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16. Receipt of live vaccine during current pregnancy. 17. High risk for preterm birth (active preterm labor, short cervix, cervical cerclage, receipt of antenatal corticosteroids for fetal lung maturity prior to Visit 1) 18. Antenatal ultrasound diagnosis of fetal growth restriction, defined as < 10th percentile estimated fetal weight for gestational age 19. Known fetal congenital anomaly, e.g. genetic abnormality or malformation based on antenatal ultrasound 20. 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.
21. Anyone who is a relative of any research study personnel 22. Anyone who is an employee of any research study personnel 23. Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product. Co-enrollment in observational or behavioral intervention studies are allowed at any time.
24. Previous participation in the study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Centers for Disease Control and Prevention
Atlanta, Georgia
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: A Prospective, Randomized, Open-label Clinical Trial to Assess the Safety and Immunogenicity of Simultaneous vs Sequential Administration of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine and Inactivated Influenza Vaccine in Pregnant Women - Pilot

This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the vaccines (IIV followed by Tdap ~ 21 days later). Vaccines will be administered by licensed study personnel.

Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review when possible.

Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on study participant preference.

Maternal serum samples will be collected for antibody titers relevant to the Tdap and Influenza at time points that include: prior to vaccination(s), ~21 days post vaccination(s), and at delivery. Additionally, cord blood serum will be analyzed for the same antibody titers.

Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained from medical record review.

Conditions: Pregnancy
Being tested: Tetanus, Diphtheria, and Pertussis Vaccine, 2016-2017 Quadrivalent Inactivated Influenza Vaccine, 2017-2018 Quadrivalent Inactivated Influenza Vaccine
Keywords: Tdap vaccine, Flu vaccine, vaccines in pregnancy, immunizations in pregnancy, Whooping Cough, Pertussis, Influenza
Medical subject headings: Influenza, Human, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tetanus, Diphtheria, and Pertussis VaccineBiological
Also called Tdap
2016-2017 Quadrivalent Inactivated Influenza VaccineBiological
Also called Flu vaccine, 2016-2017 Flu vaccine
2017-2018 Quadrivalent Inactivated Influenza VaccineBiological
Also called Flu vaccine, 2017-2018 Flu vaccine

Study groups in NCT02783170
Study group	Role	What they receive
Simultaneous vaccination arm	Other	In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1. Receives: Biological: Tetanus, Diphtheria, and Pertussis Vaccine; Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine; Biological: 2017-2018 Quadrivalent Inactivated Influenza Vaccine
Sequential vaccination arm	Other	In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4. Receives: Biological: Tetanus, Diphtheria, and Pertussis Vaccine; Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine; Biological: 2017-2018 Quadrivalent Inactivated Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Measured: 8 days post vaccine administration
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Measured: 8 days post vaccine administration
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Measured: 8 days post vaccine administration
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Measurement of serum antibody levels to pertussis antigens, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Measured: Pre-vaccination and approximately 21 days post vaccination and at Delivery
Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Measurement of serum antibody levels to diphtheria toxoids, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Measured: Pre vaccination and approximately 21 days post vaccination and at Delivery
Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Measurement of serum antibody levels to tetanus toxoids, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Measured: 21 days post vaccination
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
Measurement of serum antibody levels to influenza antigens in maternal blood and infant cord blood obtained at delivery
Measured: Pre and 21 days post vaccination and at Delivery
Percentage of Subjects Recruited Enrollment Period
Percentage of subjects recruited during 4 month enrollment period
Measured: Approximately 1 year
Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits)
Percentage of participants that completed all in-person and delivery visits
Measured: Approximately 1 year
Feasibility Reported as Percentage of Reactogenicity Data Collected
Percentage of reactogenicity data days reported (days reported / total possible days)
Measured: Approximately 1 year
Feasibility Reported as Percentage of Adequate Biospecimens Collected
Percentage of samples collected (sample timepoints collected / total possible sample timepoints)
Measured: Approximately 1 year
Feasibility Reported as Percentage of Timely Collected Biospecimens
Timeliness is defined as collected within the visit window
Measured: Approximately 1 year

Secondary outcomes (7)

Number of Participants With Adverse Maternal Outcomes
The number of participants with adverse maternal outcomes at delivery. Missing data is data not collected or unavailable.
Measured: Up to the 6-week postpartum visit
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Number of participants with adverse infant outcomes. Missing data is data not collected or unavailable.
Measured: approximately 2 months
Percentage of Participants With Clinical Chorioamnionitis
Percentage of participants with clinical chorioamnionitis
Measured: at the time of delivery
Percentage of Participants With Histologic Chorioamnionitis on Surgical Pathology Examination of Placental Tissue
Percentage of participants with histologic chorioamnionitis on surgical pathology examination of placental tissue
Measured: after delivery, approximately up to 2 weeks
Feasibility as Measured by Percentage of Blood Samples in Testable Condition
Percentage of blood samples received in testable condition (sufficient volume and quality)
Measured: Approximately 1 year
Feasibility as Measured by Percentage of Blood Samples in With Sufficient Volume for Testing
Percentage of blood samples received with sufficient volume for testing
Measured: Approximately 1 year
Feasibility as Measured by Percentage of Testable Blood Samples Completed
Percentage of testable (sufficient volume and quality) blood samples completed
Measured: Approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201610 May 2018

First posted26 May 2016 (estimated)
Study startSep 2016
Primary completion3 Apr 2018
Study completion10 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PregnancyStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02783170
Sponsor's protocol ID: Pro00071192
Acronym: Tdap/IIV
Status last verified: May 2019
First submitted: 11 May 2016
Last updated: 28 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Open-label Clinical Trial to Assess the Safety and Immunogenicity of Simultaneous vs Sequential Administration of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine and Inactivated Influenza Vaccine in Pregnant Women - Pilot
ClinicalTrials.gov ID: NCT02783170
Acronym / sponsor ID: Tdap/IIV / Pro00071192
Conditions: Pregnancy
Keywords: Tdap vaccine, Flu vaccine, vaccines in pregnancy, immunizations in pregnancy, Whooping Cough, Pertussis, Influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Children's Hospital Medical Center, Cincinnati, Centers for Disease Control and Prevention
Study start: Sep 2016
Primary completion: 3 Apr 2018 (actual)
Study completion: 10 May 2018 (actual)
First posted: 26 May 2016 (estimated)
Results: Posted 21 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review when possible.

Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained from medical record review.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Simultaneous vaccination arm	Other	Biological: Tetanus, Diphtheria, and Pertussis Vaccine, Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine, Biological: 2017-2018 Quadrivalent Inactivated Influenza VaccineIn the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Sequential vaccination arm	Other	Biological: Tetanus, Diphtheria, and Pertussis Vaccine, Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine, Biological: 2017-2018 Quadrivalent Inactivated Influenza VaccineIn this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Pregnant, as determined by medical history; 18 - 45 years of age inclusive
Intention of receiving Tdap and IIV vaccines based on Advisory Committee on Immunization Practices (ACIP) recommendations
Willing to provide written informed consent prior to initiation of any study procedures
Singleton gestation ≥ 26 weeks 0 days gestation - ≤32 weeks 0 days gestation at the time of Visit 1 vaccination 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.
English or Spanish literate

Key exclusion criteria (9 listed)

For subjects enrolling during the 2016-2017 influenza season: IIV/LAIV receipt during 2016-2017 influenza season prior to study enrollment
For subjects enrolling during the 2017-2018 influenza season: IIV/LAIV receipt during 2017-2018 influenza season prior to study enrollment
2. Tdap/Td/TT receipt during current pregnancy prior to study enrollment 3. Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
4. Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants (daily low dose aspirin may be acceptable).
5. Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to enrollment in this study.

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, Diphtheria, and Pertussis VaccineAlso: Tdap	Biological	Sequential vaccination arm, Simultaneous vaccination arm
2016-2017 Quadrivalent Inactivated Influenza VaccineAlso: Flu vaccine, 2016-2017 Flu vaccine	Biological	Sequential vaccination arm, Simultaneous vaccination arm
2017-2018 Quadrivalent Inactivated Influenza VaccineAlso: Flu vaccine, 2017-2018 Flu vaccine	Biological	Sequential vaccination arm, Simultaneous vaccination arm

Primary outcome

Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Time frame: 8 days post vaccine administration
Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Time frame: 8 days post vaccine administration
Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Time frame: 8 days post vaccine administration
Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Time frame: Pre-vaccination and approximately 21 days post vaccination and at Delivery
Measurement of serum antibody levels to pertussis antigens, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Time frame: Pre vaccination and approximately 21 days post vaccination and at Delivery
Measurement of serum antibody levels to diphtheria toxoids, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Time frame: 21 days post vaccination
Measurement of serum antibody levels to tetanus toxoids, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
Time frame: Pre and 21 days post vaccination and at Delivery
Measurement of serum antibody levels to influenza antigens in maternal blood and infant cord blood obtained at delivery
Percentage of Subjects Recruited Enrollment Period
Time frame: Approximately 1 year
Percentage of subjects recruited during 4 month enrollment period
Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits)
Time frame: Approximately 1 year
Percentage of participants that completed all in-person and delivery visits
Feasibility Reported as Percentage of Reactogenicity Data Collected
Time frame: Approximately 1 year
Percentage of reactogenicity data days reported (days reported / total possible days)
Feasibility Reported as Percentage of Adequate Biospecimens Collected
Time frame: Approximately 1 year
Percentage of samples collected (sample timepoints collected / total possible sample timepoints)
Feasibility Reported as Percentage of Timely Collected Biospecimens
Time frame: Approximately 1 year
Timeliness is defined as collected within the visit window

7 secondary outcomes

Number of Participants With Adverse Maternal Outcomes
Time frame: Up to the 6-week postpartum visit
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Time frame: approximately 2 months
Percentage of Participants With Clinical Chorioamnionitis
Time frame: at the time of delivery
Percentage of Participants With Histologic Chorioamnionitis on Surgical Pathology Examination of Placental Tissue
Time frame: after delivery, approximately up to 2 weeks
Feasibility as Measured by Percentage of Blood Samples in Testable Condition
Time frame: Approximately 1 year
Feasibility as Measured by Percentage of Blood Samples in With Sufficient Volume for Testing
Time frame: Approximately 1 year
Feasibility as Measured by Percentage of Testable Blood Samples Completed
Time frame: Approximately 1 year

Results and safety

Results posted to the registry on 21 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simultaneous Vaccination Arm	43	42
Sequential Vaccination Arm	38	38

Primary outcome: Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration

Time frame: 8 days post vaccine administration. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Simultaneous Vaccination Arm n = 42	Sequential Vaccination Arm n = 38
Flu Pain : None	47.5 (31.5 to 63.9)	48.6 (31.9 to 65.6)
Flu Pain : Mild	37.5 (22.7 to 54.2)	45.9 (29.5 to 63.1)
Flu Pain : Moderate	15.0 (5.7 to 29.8)	5.4 (0.7 to 18.2)
Flu Pain : Severe	0 (NA to 8.8)	0 (NA to 9.5)
Flu Tenderness : None	32.5 (18.6 to 49.1)	54.1 (36.9 to 70.5)
Flu Tenderness : Mild	55.0 (38.5 to 70.7)	37.8 (22.5 to 55.2)
Flu Tenderness : Moderate	12.5 (4.2 to 26.8)	8.1 (1.7 to 21.9)
Flu Tenderness : Severe	0 (NA to 8.8)	0 (NA to 9.5)

Population analysed: Safety Population - subjects that were randomized and received the study intervention

Primary outcome: Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1

Time frame: 8 days post vaccine administration. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Simultaneous Vaccination Arm n = 40	Sequential Vaccination Arm n = 37
Fever : None	100.0 (91.2 to 100)	94.6 (81.8 to 99.3)
Fever : Mild	0 (NA to 8.8)	0 (NA to 9.5)
Fever : Moderate	0 (NA to 8.8)	0 (NA to 9.5)
Fever : Severe	0 (NA to 8.8)	5.4 (0.7 to 18.2)
Abdominal Pain : None	90.0 (76.3 to 97.2)	97.3 (85.8 to 99.9)
Abdominal Pain : Mild	7.5 (1.6 to 20.4)	2.7 (0.1 to 14.2)
Abdominal Pain : Moderate	2.5 (0.1 to 13.2)	0 (NA to 9.5)
Abdominal Pain : Severe	0 (NA to 8.8)	0 (NA to 9.5)

Population analysed: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.

Primary outcome: Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4

Time frame: 8 days post vaccine administration. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Simultaneous Vaccination Arm n = 38	Sequential Vaccination Arm n = 34
Fever : None	97.4 (86.2 to 99.9)	100.0 (89.7 to 100.0)
Fever : Mild	2.6 (0.1 to 13.8)	0 (NA to 10.3)
Fever : Moderate	0 (NA to 9.3)	0 (NA to 10.3)
Fever : Severe	0 (NA to 9.3)	0 (NA to 10.3)
Abdominal Pain : None	97.4 (86.2 to 99.9)	100.0 (89.7 to 100.0)
Abdominal Pain : Mild	0 (NA to 9.3)	0 (NA to 10.3)
Abdominal Pain : Moderate	2.6 (0.1 to 13.8)	0 (NA to 10.3)
Abdominal Pain : Severe	0 (NA to 9.3)	0 (NA to 10.3)

Population analysed: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.

Primary outcome: Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers

Time frame: Pre-vaccination and approximately 21 days post vaccination and at Delivery. Geometric mean (95% Confidence Interval). Unit: Concentration (IU/mL)

Measure	Simultaneous Vaccination Arm n = 42	Sequential Vaccination Arm n = 38
Pre-Vaccination - FHA	27.5 (18.5 to 41.0)	37.0 (23.8 to 57.6)
Pre-Vaccination - FIM	87.3 (46.9 to 162.4)	20.8 (10.5 to 41.1)
Pre-Vaccination - PRN	44.8 (27.3 to 73.7)	47.1 (26.4 to 83.9)
Pre-Vaccination - PT	7.8 (5.1 to 11.9)	5.9 (3.5 to 10.1)
Post-Vaccination - FHA	171.3 (135.0 to 217.7)	262.1 (201.5 to 341.0)
Post-Vaccination - FIM	99.9 (55.9 to 178.7)	19.7 (10.2 to 38.1)
Post-Vaccination - PRN	242.1 (178.1 to 329.2)	360.4 (240.8 to 539.4)
Post-Vaccination - PT	37.6 (26.8 to 52.9)	38.6 (28.4 to 52.3)

Population analysed: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and SAEs are captured up to 8 days post vaccination. Subjects are followed for SAEs up to the 6-week postpartum visit. Significant infant complications or SAEs identified during the delivery visit will be followed up to the 2-month well child visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simultaneous Vaccination Arm	1 of 42 (2.4%)	2 of 42 (4.8%)	0 of 42
Sequential Vaccination Arm	0 of 38 (0%)	2 of 38 (5.3%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge

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.

Geeta Swamy, MD principal investigator

Duke University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration (time frame: 8 days post vaccine administration). The study lists 12 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 NCT02783170.

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 28 Jul 2025.