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Trial record 1 of 1 for:    tdap iiv pregnant
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Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women (Tdap/IIV)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Duke University
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02783170
First received: May 11, 2016
Last updated: December 9, 2016
Last verified: December 2016
  Purpose

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.


Condition Intervention Phase
Pregnancy Biological: Tetanus, Diphtheria, and Pertussis Vaccine Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Proportion of Injection-site Reactions post Tdap and Flu administration [ Time Frame: 7 days post vaccine administration ]
    Proportions of injection-site reactions will be compared in simultaneous and sequential groups

  • Proportions of Systemic Reactions post Tdap and Flu administration [ Time Frame: 7 days post vaccine administration ]
    Proportions of systemic reactions will be compared in simultaneous and sequential groups

  • Pertussis Serum Antibody Levels, as measured by Geometric mean titers [ Time Frame: Pre vaccination and 21 days post vaccination and at Delivery ]
    Measurement of serum antibody levels to pertussis antigens, in maternal blood and infant cord blood obtained at delivery

  • Diphtheria Serum Antibody Levels, as measured by the proportion of subjects with seroprotection (defined as > 0.1 IU/mL) [ Time Frame: 21 days post vaccination ]
    Measurement of serum antibody levels to diphtheria toxoids, in maternal blood and infant cord blood obtained at delivery

  • Tetanus Serum Antibody Levels, as measured by the proportion of subjects with seroprotection (defined as > 0.1 IU/mL) [ Time Frame: 21 days post vaccination ]
    Measurement of serum antibody levels to tetanus toxoids, in maternal blood and infant cord blood obtained at delivery

  • Flu Serum Antibody Levels, as measured by proportion of subjects with seroprotection (pre- and post-immunization) and seroconversion (4-fold rise from baseline) [ 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

  • feasibility as measured by number of participants recruited [ Time Frame: Approximately 1 year ]
  • feasibility as measured by participant retention (percentage of participants who complete all visits) [ Time Frame: Approximately 1 year ]
  • feasibility reported as percentage of adequate data collected [ Time Frame: Approximately 1 year ]
  • feasibility reported as percentage of adequate biospecimens collected [ Time Frame: Approximately 1 year ]
  • feasibility reported as percentage of timely collected biospecimens [ Time Frame: Approximately 1 year ]
  • feasibility reported as percentage of timely collected data [ Time Frame: Approximately 1 year ]

Secondary Outcome Measures:
  • Proportion of adverse maternal outcomes based on medical record review [ Time Frame: Up to the 6-week postpartum visit ]
  • Proportion of adverse infant outcomes based on medical record review [ Time Frame: approximately 2 months ]
  • Proportion of clinical chorioamnionitis [ Time Frame: at the time of delivery ]
  • Proportion of 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 benchmarks for analyzing pertussis immunogenicity at the CDC laboratories.

  • feasibility as measured by percentage of blood samples in with sufficient volume for testing [ Time Frame: Approximately 1 year ]
    Feasibility benchmarks for analyzing pertussis immunogenicity at the CDC laboratories.

  • feasibility as measured by percentage of testable blood samples completed [ Time Frame: Approximately 1 year ]
    Feasibility benchmarks for analyzing pertussis immunogenicity at the CDC laboratories.


Estimated Enrollment: 50
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Simultaneous vaccination arm
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Biological: Tetanus, Diphtheria, and Pertussis Vaccine
Other Name: Tdap
Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine
Other Names:
  • Flu vaccine
  • 2016-2017 Flu vaccine
Sequential vaccination arm
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.
Biological: Tetanus, Diphtheria, and Pertussis Vaccine
Other Name: Tdap
Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine
Other Names:
  • Flu vaccine
  • 2016-2017 Flu vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant, as determined by medical history; 18 - 45 years of age inclusive
  2. Intention of receiving Tdap and IIV vaccines based on Advisory Committee on Immunization Practices (ACIP) recommendations
  3. Willing to provide written informed consent prior to initiation of any study procedures
  4. 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.
  5. English or Spanish literate
  6. Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information.

Exclusion Criteria:

  1. IIV/LAIV receipt during 2016-2017 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02783170

Contacts
Contact: Geeta Swamy, MD 919-681-5220 geeta.swamy@dm.duke.edu
Contact: Kristin Weaver, BS 919-681-0308 kristin.weaver@dm.duke.edu

Locations
United States, Georgia
Centers for Disease Control and Prevention Active, not recruiting
Atlanta, Georgia, United States
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Geeta Swamy, MD    919-681-5220    geeta.swamy@dm.duke.edu   
Contact: Kristin Weaver, BS    919-681-0308    kristin.weaver@dm.duke.edu   
Principal Investigator: Geeta Swamy, MD         
Sub-Investigator: Emmanuel Walter, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Elizabeth Schlaudecker, MD, MPH    513-803-5183    Elizabeth.Schlaudecker@cchmc.org   
Contact: Steve Black, MD    513-803-0747    Steven.Black1@cchmc.org   
Principal Investigator: Elizabeth Schlaudecker, MD, MPH         
Sub-Investigator: Steve Black, MD         
Sponsors and Collaborators
Duke University
Children's Hospital Medical Center, Cincinnati
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Geeta Swamy, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02783170     History of Changes
Other Study ID Numbers: Pro00071192
Study First Received: May 11, 2016
Last Updated: December 9, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Duke University:
Tdap vaccine
Flu vaccine
vaccines in pregnancy
immunizations in pregnancy
Whooping Cough
Pertussis
Influenza

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017