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This refers to the co-administration of a quadrivalent inactivated influenza vaccine (IIV4) and an mRNA COVID-19 vaccine, currently being evaluated in a Phase 4 clinical trial led by Duke University (NCT06503900). The study specifically investigates the safety and immunogenicity of simultaneous versus sequential administration in pregnant women. The IIV4 component is a standard seasonal vaccine containing hemagglutinin antigens from four influenza strains: two influenza A subtypes (H1N1 and H3N2) and two influenza B lineages (Victoria and Yamagata). The mRNA COVID-19 vaccine component (such as those developed by Pfizer-BioNTech or Moderna) encodes the SARS-CoV-2 spike protein to elicit a protective immune response. The trial aims to optimize vaccination schedules for pregnant populations to ensure protection against both seasonal influenza and COVID-19 while monitoring local and systemic reactogenicity and placental antibody transfer.
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