{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T05:25:16Z","timestamp":1784697916417,"version":"3.55.0"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,3,26]],"date-time":"2023-03-26T00:00:00Z","timestamp":1679788800000},"content-version":"vor","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Influenza Resp Viruses"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Seasonal influenza epidemics are managed through vaccination each winter in the European Union, to prevent infections, complications, and deaths. As circulating virus strains vary unpredictably, vaccines are reformulated annually, and their safety monitored rapidly and continuously at the start of each season, following European Medicines Agency guidelines.Seasonal influenza epidemics are managed through vaccination each winter in the European Union, to prevent infections, complications, and deaths. As circulating virus strains vary unpredictably, vaccines are reformulated annually, and their safety monitored rapidly and continuously at the start of each season, following European Medicines Agency guidelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This enhanced safety surveillance study assessed pre\u2010specified and other adverse events (AEs) occurring within 7\u2009days of GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in children and adults in Spain and Germany. As the study was conducted during the COVID\u201019 pandemic (2021\/2022 season), data were collected electronically, using a web portal or call center.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Safety was assessed in 737 participants (median age 49 and 9\u2009years in Germany and Spain, respectively, 19.3% with a chronic medical condition). After Dose 1 and Dose 2, respectively, 332 (45.1%) and 5 (26.3%) participants reported at least one AE, primarily pre\u2010specified AEs. The most common AEs after Dose 1 (adults and children) were injection site pain, swelling or erythema, headache, and fatigue. After Dose 2 (in children), the most common AEs were injection site pain, rhinorrhea, fatigue, and decreased appetite. No new or unexpected safety issues were identified.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study supports and confirms the safety profile of GSK's IIV4 in all age groups with a vaccine indication. The new electronic safety reporting method (with response rates of 75.4% following Dose 1 and 100% following Dose 2) provides an alternative for future studies to reduce the burden on sites or in case site visits are not feasible.<\/jats:p><\/jats:sec>","DOI":"10.1111\/irv.13098","type":"journal-article","created":{"date-parts":[[2023,3,27]],"date-time":"2023-03-27T06:24:11Z","timestamp":1679898251000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021\/2022 season) using an electronic patient\u2010reported outcome system for vaccine safety remote monitoring"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8623-3478","authenticated-orcid":false,"given":"Ga\u00ebl","family":"Dos Santos","sequence":"first","affiliation":[{"name":"GSK  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamara","family":"Eckermann","sequence":"additional","affiliation":[{"name":"Hausarztpraxis Heimeranplatz  Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4583-9734","authenticated-orcid":false,"given":"Xavier","family":"Mart\u00ednez\u2010G\u00f3mez","sequence":"additional","affiliation":[{"name":"Hospital Universitari Vall d'Hebron  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5152-4715","authenticated-orcid":false,"given":"Jose","family":"Parra","sequence":"additional","affiliation":[{"name":"GSK  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2946-703X","authenticated-orcid":false,"given":"Ugo","family":"Nwoji","sequence":"additional","affiliation":[{"name":"GSK  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0561-9913","authenticated-orcid":false,"given":"Ignacio","family":"Salamanca de la Cueva","sequence":"additional","affiliation":[{"name":"Instituto Hispalense de Pediatr\u00eda  Sevilla Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,3,26]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"European Centre for Disease Prevention and Control (ECDC).Factsheet about seasonal influenza.2022;https:\/\/ecdc.europa.eu\/en\/seasonal-influenza\/facts\/factsheet. Accessed November 30 2022."},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2021.11.080"},{"key":"e_1_2_13_4_1","unstructured":"European Centre for Disease Prevention and Control (ECDC).Communicable disease threats report\u2014week 11 13\u201019 March 2022.2022;https:\/\/www.ecdc.europa.eu\/sites\/default\/files\/documents\/Communicable-disease-threats-report-19-mar-2022-public.pdf. Accessed July 6 2022."},{"key":"e_1_2_13_5_1","unstructured":"World Health Organisation (WHO).WHO Regional Office for Europe recommendations on influenza vaccination for the 2021\/2022 season during the ongoing COVID\u201019 pandemic.2021;https:\/\/apps.who.int\/iris\/handle\/10665\/347890. Accessed July 6 2022."},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2015.1086047"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1089\/vim.2017.0141"},{"key":"e_1_2_13_8_1","unstructured":"European Medicines Agency (EMA).Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU 2014;http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2014\/04\/WC500165492.pdf. Accessed April 1 2019."},{"key":"e_1_2_13_9_1","unstructured":"European Medicines Agency (EMA).Guideline on influenza vaccines\u2014non\u2010clinical and clinical module.2016;https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/influenza-vaccines-non-clinical-clinical-module_en.pdf. Accessed July 6 2022."},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2019.1608745"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.2196\/12016"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2019.1565258"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2019.1705112"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010019\u201000893\u20104"},{"key":"e_1_2_13_15_1","unstructured":"European Centre for Disease Prevention and Control (ECDC).Vaccine schedules in all countries of the European Union.2018;https:\/\/vaccine-schedule.ecdc.europa.eu\/. Accessed July 1 2019."},{"key":"e_1_2_13_16_1","unstructured":"Medical Dictionary for Regulatory Activities MedDRA.https:\/\/www.meddra.org\/basics. Accessed April 1 2019."},{"key":"e_1_2_13_17_1","unstructured":"GSK.GSK study register\u2014enhanced safety surveillance of GSKs quadrivalent seasonal influenza vaccines: GSK Study ID: 213828 (2021\u201322).2022;https:\/\/www.gsk-studyregister.com\/en\/trial-details\/?id=213828. Accessed September 26 2022. [Study protocols and study results will be available by March 2023]."},{"key":"e_1_2_13_18_1","unstructured":"World Health Organisation (WHO).Recommended composition of influenza virus vaccines for use in the 2021\u20132022 northern hemisphere influenza season.2021;https:\/\/www.who.int\/publications\/i\/item\/recommended-composition-of-influenza-virus-vaccines-for-use-in-the-2021-2022-northern-hemisphere-influenza-season. 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