Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season

Ignacio Salamanca de la Cueva, Elisa Cinconze, Tamara Eckermann, Ugo Nwoji, Lode Godderis, Emily Lu, Xavier Martínez-Gómez, Huajun Wang and Emad Yanni ()
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Ignacio Salamanca de la Cueva: Instituto Hispalense de Pediatría
Elisa Cinconze: GSK
Tamara Eckermann: Hausarztpraxis Heimeranplatz
Ugo Nwoji: GSK
Lode Godderis: KU Leuven
Emily Lu: GSK
Xavier Martínez-Gómez: Hospital Universitari Vall d’Hebron
Huajun Wang: GSK
Emad Yanni: GSK

Drug Safety, 2021, vol. 44, issue 12, No 11, 1375-1390

Abstract: Abstract Introduction Seasonal influenza infects millions annually in Europe. Annual influenza vaccination is the most effective measure to reduce the risk of infection and its complications, especially among young children and older adults. Objective We assessed adverse event (AE) frequency after receiving GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4). Methods A passive enhanced safety surveillance study was conducted in Belgium, Germany, and Spain. Adults who had received GSK's IIV4 or the parent(s)/guardian(s)/legally acceptable representative(s) of children given the vaccine were invited to complete an adverse drug reaction (ADR) card to document AEs experienced within 7 days post vaccination. Results A total of 1082 participants (51.6% females) received GSK's IIV4, including 115 children

Date: 2021
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DOI: 10.1007/s40264-021-01121-8

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