ArticleInfectious diseases and therapy2026
Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China: A Phase IV Study.
Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionThe aim of this work is to preliminarily evaluate the post-marketing safety of a quadrivalent subunit influenza vaccine in healthy individuals aged 3 years and above through active surveillance of adverse reactions following vaccination.
methodsDuring the 2024-2025 influenza season, healthy participants aged 3 years and older were enrolled in Jiangsu Province. All participants received a single dose of the quadrivalent subunit influenza vaccine. Adverse events (AEs) and serious adverse events (SAEs) were monitored within 0-28 days post-vaccination, and information on SAEs occurring within 6 months post-vaccination was also collected. Descriptive analyses were performed to calculate the reporting rates of AEs, adverse drug reactions (ADRs) and SAEs. We compared differences in overall and symptom-specific ADR reporting rates across age groups and sexes.
resultsA total of 3105 participants completed vaccination and were included in the safety analysis set. A total of 282 participants reported 477 AEs, yielding an overall AE reporting rate of 9.08%. A total of 188 participants reported 318 ADRs, with an ADR reporting rate of 6.05%. The most frequently reported ADR symptoms were tenderness (69 episodes, reporting rate 2.22%), cough (57 episodes, 1.83%), and fever (46 episodes, 1.48%). The majority of ADRs (272 episodes, 85.53%) were grade 1 in severity, and most symptoms (253 episodes, 79.56%) resolved within 3 days of onset. No vaccine-related SAEs were reported, and no new serious adverse reactions were identified.
conclusionsThis active surveillance study demonstrated a favorable safety profile for the quadrivalent subunit influenza vaccine, with low ADR reporting rates and predominantly mild, transient reactions. These findings provide reliable evidence supporting the preliminary post-marketing safety assessment of the vaccine in China.
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