biostudies-literatureUnknown47(4)Dos Santos GGlaxoSmithKline Biologicals SA<h4>Introduction</h4>Seasonal influenza is associated with substantial public health burden. The objective of this study was to assess the safety of inactivated quadrivalent seasonal influenza vaccine (IIV4, Fluarix Tetra, GSK, Belgium) in subjects aged ≥ 6 months in Korea.<h4>Methods</h4>This prospective, observational, non-comparative, multi-centre post-marketing surveillance study was conducted in Korea in subjects aged ≥ 3 years for 6 years (2014-2020) and extended to subjects aged 6-35 months for 4 years (2018-2022). Subjects received IIV4 in routine clinical practice according to local prescribing information. Adverse events (AEs) were recorded over 21 days post-vaccination.<h4>Results</h4>The group aged ≥ 3 years included 701 subjects (mean 31.97 years, range 3-86 years, 46.36% maleDrug safety365-375https://www.ebi.ac.uk/biostudies/studies/S-EPMC10955014biostudies-literatureAn 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014-2022) Following the Introduction of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older.PMC10955014Kim CSDos Santos GDevadiga RBang JfalseAn 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014-2022) Following the Introduction of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older.<h4>Introduction</h4>Seasonal influenza is associated with substantial public health burden. The objective of this study was to assess the safety of inactivated quadrivalent seasonal influenza vaccine (IIV4, Fluarix Tetra, GSK, Belgium) in subjects aged ≥ 6 months in Korea.<h4>Methods</h4>This prospective, observational, non-comparative, multi-centre post-marketing surveillance study was conducted in Korea in subjects aged ≥ 3 years for 6 years (2014-2020) and extended to subjects aged 6-35 months for 4 years (2018-2022). Subjects received IIV4 in routine clinical practice according to local prescribing information. Adverse events (AEs) were recorded over 21 days post-vaccination.<h4>Results</h4>The group aged ≥ 3 years included 701 subjects (mean 31.97 years, range 3-86 years, 46.36% male2024-01-01T00:00:00Z2024 Apr2026-07-14T23:58:01.366Z2026-06-26T03:21:47.482ZS-EPMC109550143848376710.1007/s40264-024-01395-8