Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Nov;47(11):1137-1148.
doi: 10.1007/s40264-024-01456-y. Epub 2024 Jun 29.

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

Affiliations

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

Ignacio Salamanca de la Cueva et al. Drug Saf. 2024 Nov.

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

Carlos Brotons, Ignacio Salamanca, Tamara Eckermann, and Falko Panzer declare that their institution received payment from GSK for the conduct of the study. Xavier Martínez‐Gómez declares having received payment or honoraria for lectures, presentations, meetings, or educational events from AstraZeneca and Pfizer. Andrew Hastie, Jean-Yves Pirçon, Jennifer E. Gerber, Vanja Nikic, and Hannah Alsdurf were employees of the GSK group of companies. Andrew Hastie, Jean-Yves Pirçon, and Vanja Nikic possesses stock options in GSK. Paul Talsma was an employee of the GSK group of companies at the time of the study. The authors declare no other financial and non‐financial relationships and activities.

Figures

Fig. 1
Fig. 1
Study attrition diagram/disposition. GSK GlaxoSmithKline, IIV4 inactivated quadrivalent seasonal influenza vaccine, N, total number, n, number in subcategory. aParticipant did not complete the adverse drug reaction card or did not return it within the allowed time frame

Similar articles

References

    1. World Health Organization (WHO). Influenza (seasonal). Available from: https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal). [Accessed 26 Sep 2023].
    1. Krammer F, Smith GJD, Fouchier RAM, Peiris M, Kedzierska K, Doherty PC, et al. Influenza. Nat Rev Dis Primers. 2018;4(1):3. 10.1038/s41572-018-0002-y. - PMC - PubMed
    1. European Centre for Disease Prevention and Control (ECDC). Factsheet about seasonal influenza. Available from: https://www.ecdc.europa.eu/en/seasonal-influenza/facts/factsheet. [Accessed 26 Sep 2023].
    1. Paget J, Iuliano AD, Taylor RJ, Simonsen L, Viboud C, Spreeuwenberg P, et al. Estimates of mortality associated with seasonal influenza for the European Union from the GLaMOR project. Vaccine. 2022;40(9):1361–9. 10.1016/j.vaccine.2021.11.080. - PMC - PubMed
    1. Iuliano AD, Roguski KM, Chang HH, Muscatello DJ, Palekar R, Tempia S, et al. Estimates of global seasonal influenza-associated respiratory mortality: a modelling study. Lancet. 2018;391(10127):1285–300. 10.1016/S0140-6736(17)33293-2. - PMC - PubMed

MeSH terms

LinkOut - more resources