(Respiratory Syncytial Virus Vaccine)
In Study 6 (NCT04071158) in a concomitant administration study of ABRYSVO and a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) in non-pregnant women, no safety concerns were identified. Immune responses to RSV A, RSV B, diphtheria, and tetanus were non-inferior to those after separate administration. Lower geometric mean antibody concentrations (GMCs) to the acellular pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin (FHA), and pertactin [PRN]) were measured when ABRYSVO was administered concomitantly with Tdap compared to pertussis GMCs when Tdap was administered alone [see Clinical Studies (14.5)].
Concomitant administration of Tdap with ABRYSVO in pregnant individuals has not been studied.
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