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.
Age range
18 Years – 45 Years
Sex
FEMALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Timeframe: 8 days post vaccine administration
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Timeframe: 8 days post vaccine administration
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Timeframe: 8 days post vaccine administration
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Timeframe: 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)
Timeframe: 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)
Timeframe: 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) )
Timeframe: Pre and 21 days post vaccination and at Delivery
Percentage of Subjects Recruited Enrollment Period
Timeframe: Approximately 1 year
Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits)
Timeframe: Approximately 1 year
Feasibility Reported as Percentage of Reactogenicity Data Collected
Timeframe: Approximately 1 year
Feasibility Reported as Percentage of Adequate Biospecimens Collected
Timeframe: Approximately 1 year
Feasibility Reported as Percentage of Timely Collected Biospecimens
Timeframe: Approximately 1 year