Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season

Background: Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring. Objective: We assessed the frequency and severity of adver...

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Autores: de la Cueva, I.S., Gerber, J.E., Hastie, A., Brotons, Carlos|||0000-0001-9388-6581, Panzer, F., Pirçon, J.Y., Talsma, P., Eckermann, T., Nikic, V., Martínez Gómez, Xavier|||0000-0003-4583-9734, Alsdurf, H.
Tipo de recurso: artículo
Fecha de publicación:2024
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:307621
Acceso en línea:https://ddd.uab.cat/record/307621
https://dx.doi.org/urn:doi:10.1007/s40264-024-01456-y
Access Level:acceso abierto
Palabra clave:Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Aged
Belgium
Child
Child, Preschool
Female
Germany
Humans
Infant
Influenza Vaccines
Influenza, Human
Male
Middle Aged
Seasons
Spain
Vaccination
Vaccines, Inactivated
Young Adult
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spelling Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Seasonde la Cueva, I.S.Gerber, J.E.Hastie, A.Brotons, Carlos|||0000-0001-9388-6581Panzer, F.Pirçon, J.Y.Talsma, P.Eckermann, T.Nikic, V.Martínez Gómez, Xavier|||0000-0003-4583-9734Alsdurf, H.AdolescentAdultAdverse Drug Reaction Reporting SystemsAgedBelgiumChildChild, PreschoolFemaleGermanyHumansInfantInfluenza VaccinesInfluenza, HumanMaleMiddle AgedSeasonsSpainVaccinationVaccines, InactivatedYoung AdultBackground: Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring. Objective: We assessed the frequency and severity of adverse events within 7 days of administering GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season. Methods: In this enhanced safety surveillance study, adults who received GSK's IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months-17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination. Results: In total, 1332 participants (53.6% female) received at least one dose of GSK's IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months-17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency.Universitat Autònoma de Barcelona 22024-01-0120242024-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/307621https://dx.doi.org/urn:doi:10.1007/s40264-024-01456-yreponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3076212026-06-06T12:50:31Z
dc.title.none.fl_str_mv Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
title Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
spellingShingle Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
de la Cueva, I.S.
Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Aged
Belgium
Child
Child, Preschool
Female
Germany
Humans
Infant
Influenza Vaccines
Influenza, Human
Male
Middle Aged
Seasons
Spain
Vaccination
Vaccines, Inactivated
Young Adult
title_short Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
title_full Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
title_fullStr Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
title_full_unstemmed Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
title_sort Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
dc.creator.none.fl_str_mv de la Cueva, I.S.
Gerber, J.E.
Hastie, A.
Brotons, Carlos|||0000-0001-9388-6581
Panzer, F.
Pirçon, J.Y.
Talsma, P.
Eckermann, T.
Nikic, V.
Martínez Gómez, Xavier|||0000-0003-4583-9734
Alsdurf, H.
author de la Cueva, I.S.
author_facet de la Cueva, I.S.
Gerber, J.E.
Hastie, A.
Brotons, Carlos|||0000-0001-9388-6581
Panzer, F.
Pirçon, J.Y.
Talsma, P.
Eckermann, T.
Nikic, V.
Martínez Gómez, Xavier|||0000-0003-4583-9734
Alsdurf, H.
author_role author
author2 Gerber, J.E.
Hastie, A.
Brotons, Carlos|||0000-0001-9388-6581
Panzer, F.
Pirçon, J.Y.
Talsma, P.
Eckermann, T.
Nikic, V.
Martínez Gómez, Xavier|||0000-0003-4583-9734
Alsdurf, H.
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Aged
Belgium
Child
Child, Preschool
Female
Germany
Humans
Infant
Influenza Vaccines
Influenza, Human
Male
Middle Aged
Seasons
Spain
Vaccination
Vaccines, Inactivated
Young Adult
topic Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Aged
Belgium
Child
Child, Preschool
Female
Germany
Humans
Infant
Influenza Vaccines
Influenza, Human
Male
Middle Aged
Seasons
Spain
Vaccination
Vaccines, Inactivated
Young Adult
description Background: Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring. Objective: We assessed the frequency and severity of adverse events within 7 days of administering GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season. Methods: In this enhanced safety surveillance study, adults who received GSK's IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months-17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination. Results: In total, 1332 participants (53.6% female) received at least one dose of GSK's IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months-17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency.
publishDate 2024
dc.date.none.fl_str_mv 2
2024-01-01
2024
2024-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/307621
https://dx.doi.org/urn:doi:10.1007/s40264-024-01456-y
url https://ddd.uab.cat/record/307621
https://dx.doi.org/urn:doi:10.1007/s40264-024-01456-y
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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