Pregnancy Clinical Trial
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.
n/a
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