SEARCHCOHORTinfectious disease, public health

cohort·infectious disease, public health, epidemiology, pediatrics, clinical trial·PMC10040952

Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021/2022 season) using an electronic patient‐reported outcome system for vaccine safety remote monitoring

Influenza and Other Respiratory Viruses · 6 authors, 5 centres

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FIDELITY 100%

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AGENT 01 · STRUCTURED SUMMARY

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TL;DR

The study found no new or unexpected safety issues, confirming the vaccine's known safety profile.

Full summary

740 CHARS

This enhanced safety surveillance study conducted during the 2021/2022 season assessed the safety of GSK's quadrivalent inactivated influenza vaccine (IIV4) in 737 participants (children and adults) in Germany and Spain. After Dose 1, 332 (45.1%) participants reported at least one AE, with injection site reactions, headache, and fatigue being most common. After Dose 2, 5 (26.3%) participants reported AEs. The study identified no new or unexpected safety issues, and the reported AE rates were consistent with the vaccine's established safety profile. The study demonstrates that electronic patient-reported outcome systems can effectively support near real-time vaccine safety monitoring, particularly when site visits are not feasible.

STUDY TYPE

cohort

SPECIALTY

infectious disease

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10040952

Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021/2022 season) using an electronic patient‐reported outcome system for vaccine safety remote monitoring

Influenza and Other Respiratory Viruses

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ABSTRACT

Abstract Background 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. Methods This enhanced safety surveillance study assessed pre‐specified and other adverse events (AEs) occurring within 7 days 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‐19 pandemic (2021/2022 season), data were collected electronically, using a web portal or call center. Results Safety was assessed in 737 participants (median age 49 and 9 years 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‐specified 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. Conclusion 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.

CITATION EXPORT

Gaël Dos Santos, Tamara Eckermann, Xavier Martínez‐Gómez et al.. Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021/2022 season) using an electronic patient‐reported outcome system for vaccine safety remote monitoring. Influenza and Other Respiratory Viruses. (2023). https://doi.org/10.1111/irv.13098

AUTHORS

6 · 5 CENTRES

Gaël Dos Santos, Tamara Eckermann, Xavier Martínez‐Gómez, Jose Parra, Ugo Nwoji, Ignacio Salamanca de la Cueva

1 GSK Wavre Belgium
2 Hausarztpraxis Heimeranplatz Munich Germany
3 Hospital Universitari Vall d'Hebron Barcelona Spain
4 GSK Rockville Maryland USA
5 Instituto Hispalense de Pediatría Sevilla Spain