Yoo BW, Kim CO, Izu A, Arora AK, Heijnen E. Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD? and VANTAFLU? in South Korean Subjects Aged ≥65 Years. Infect Chemother. 2018 Dec;50(4):301-310
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? and VANTAFLU?, 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?, n = 389; VANTAFLU?, 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? or VANTAFLU? had acceptable safety profiles in older adults (aged ≥65 years) in South Korea.
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? and VANTAFLU?, 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?, n = 389; VANTAFLU?, 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? or VANTAFLU? had acceptable safety profiles in older adults (aged ≥65 years) in South Korea.
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