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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
81
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre and 21 days post vaccination and at Delivery
Percentage of Subjects Recruited Enrollment Period
Percentage of subjects recruited during 4 month enrollment period
Time frame: 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
Time frame: Approximately 1 year
Feasibility Reported as Percentage of Reactogenicity Data Collected
Percentage of reactogenicity data days reported (days reported / total possible days)
Time frame: Approximately 1 year
Feasibility Reported as Percentage of Adequate Biospecimens Collected
Percentage of samples collected (sample timepoints collected / total possible sample timepoints)
Time frame: Approximately 1 year
Feasibility Reported as Percentage of Timely Collected Biospecimens
Timeliness is defined as collected within the visit window
Time frame: Approximately 1 year
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.
Time frame: 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.
Time frame: approximately 2 months
Percentage of Participants With Clinical Chorioamnionitis
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
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
Percentage of blood samples received in testable condition (sufficient volume and quality)
Time frame: 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
Time frame: Approximately 1 year
Feasibility as Measured by Percentage of Testable Blood Samples Completed
Percentage of testable (sufficient volume and quality) blood samples completed
Time frame: Approximately 1 year
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