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

Autor: de la Cueva IS; Instituto Hispalense de Pediatría, Seville, Spain., Gerber JE; GSK, 14200 Shady Grove Road, Rockville, MD, 20850, USA., Hastie A; GSK, 14200 Shady Grove Road, Rockville, MD, 20850, USA., Brotons C; Biomedical Research Institute Sant Pau, EAP Sardenya, Barcelona, Spain., Panzer F; PaedResearch, Mannheim, Germany., Pirçon JY; GSK, Wavre, Belgium., Talsma P; Statistics Department, Vivos Technology Limited (Phastar), London, UK., Eckermann T; Studienpraxis Heimeranplatz, München, Germany., Nikic V; GSK, 14200 Shady Grove Road, Rockville, MD, 20850, USA., Gomez XM; Department of Preventive Medicine, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Alsdurf H; GSK, 14200 Shady Grove Road, Rockville, MD, 20850, USA. hannah.m.alsdurf@gsk.com.
Jazyk: angličtina
Zdroj: Drug safety [Drug Saf] 2024 Nov; Vol. 47 (11), pp. 1137-1148. Date of Electronic Publication: 2024 Jun 29.
DOI: 10.1007/s40264-024-01456-y
Abstrakt: 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 >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.
Clinical Trial Registration: ClinicalTrials.gov number: not applicable.
(© 2024. GSK.)
Databáze: MEDLINE
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