2026-04-13T01:29:19Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/121142025-10-24T10:25:58Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Salamanca de la Cueva, Ignacio
author
Gerber, Jennifer
author
Hastie, Andrew
author
Brotons, Carlos
author
PANZER, Falko
author
Pirçon, Jean-Yves
author
Martínez-Gómez, Xavier
2025-10-24T10:25:58Z
2025-10-24T10:25:58Z
2024-10-23T12:29:49Z2024-10-23T12:29:49Z2024-11
http://hdl.handle.net/11351/12114
Safety surveillance; Influenza Vaccine; Influenza seasonVigilancia de seguridad; Vacuna antigripal; Gripe estacionalVigilància de seguretat; Vacuna antigripal; Grip estacionalBackground
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 >5%) following Dose 1 were injection-site pain (37.6%), fatigue (15.0%), headache (13.2%), injection-site swelling (9.3%), myalgia (7.6%), and injection-site erythema (7.4%). Across all countries, adverse events were most common in adults aged 18–65 years (59.7%), followed by those aged 3–17 years (47.0%), >65 years (35.7%), and 6–35 months (23.5%). After Dose 2, 18.6% of participants reported at least one adverse event, with general disorders and administration site conditions again being the most frequent.
Conclusions
Across all age and risk groups for serious disease, no serious adverse events related to GSK’s IIV4 were reported within 7 days post-vaccination. This study supports and confirms the acceptable safety profile of GSK’s IIV4 across all recommended age groups.GlaxoSmithKline Biologicals S.A funded this study (GlaxoSmithKline [GSK] study identifier: 213829) and was involved in all stages of the study, including analysis of the data. GlaxoSmithKline Biologicals S.A also funded all costs associated with the development and publishing of the manuscript.
Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
Grip - Vacunació
Vacunes antigripals
Virus de la grip
DISEASES::Virus Diseases::RNA Virus Infections::Orthomyxoviridae Infections::Influenza, Human
Other subheadings::Other subheadings::Other subheadings::/prevention & control
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::Vaccination
Other subheadings::Other subheadings::Other subheadings::/adverse effects
CHEMICALS AND DRUGS::Complex Mixtures::Biological Products::Vaccines::Vaccines, Inactivated
ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Orthomyxoviridae::gripe humana
Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::inmunomodulación::inmunoterapia::inmunización::inmunoterapia activa::vacunación
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
COMPUESTOS QUÍMICOS Y DROGAS::mezclas complejas::productos biológicos::vacunas::vacunas inactivadas
Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion