Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD (R) and VANTAFLU (R) in South Korean Subjects Aged >= 65 Years

초록

Backgroud: Influenza vaccination is recommended for adults aged >= 65 years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as FLUAD (R) and VANTAFLU (R), in South Korean subjects aged >= 65 years. Materials and Methods: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAES) were recorded from day 1 until study termination (day 29). Results: Of the 770 subjects enrolled (FLUAD (R), n = 389; VANTAFLU (R), n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). Conclusion: These results show that the MF59-adjuvanted influenza vaccine known as FLUAD (R) or VANTAFLU (R) had acceptable safety profiles in older adults (aged >= 65 years) in South Korea.

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