ScholarWorks@성균관대학교

초록

Background/Objectives: Influenza poses a significant risk for young children, particularly those under five. Cell culture-derived influenza vaccines offer advantages in reducing adaptive changes and mitigating egg allergy concerns. SKYCellflu (R) quadrivalent has been in use since 2015, and this study aimed to assess its safety and influenza infections in children aged 6-35 months in South Korea. Methods: A prospective cohort, non-interventional, multi-center post-marketing surveillance study was conducted from 2020 to 2024. This study presents data from the 2023-2024 influenza season on safety and influenza infections in children aged 6-35 months following SKYCellflu (R) vaccination. Safety was assessed based on adverse events (AEs) within 28 days post-vaccination, and influenza infections were assessed via phone calls or medical record screening. Results: Among 333 safety set participants, 54.4% reported at least one AE, with most being mild to moderate. The cumulative incidence of influenza infections among 247 ad hoc subsets was 4.5%, and the incidence rate was 1.3 per 100 person-months (95% CI, 0.7-2.4) during the 2023-2024 influenza season. The two-dose regimen in vaccine-na & iuml;ve infants aged 6-11 months showed a lower cumulative incidence of influenza infection rate (0.8% vs. 3.8%) and incidence rate (0.3 vs. 0.9 per 100 person-months) than the one-dose group (3.8%). No influenza-related hospitalizations occurred within the ad hoc subset. Conclusions: This study demonstrated a tolerable safety profile and the pattern of influenza infections following SKYCellflu (R) vaccination. Additionally, the two-dose regimen was associated with a lower incidence of influenza infections, suggesting potential benefits in enhancing protection among infants aged 6-11 months.

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