tetano
Editor, Senior Moderator
Infect Chemother. 2018 Dec;50(4):301-310. doi: 10.3947/ic.2018.50.4.301.
[h=1]Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD? and VANTAFLU? in South Korean Subjects Aged ≥65 Years.[/h] Yoo BW[SUP]1[/SUP], Kim CO[SUP]2[/SUP], Izu A[SUP]3[/SUP], Arora AK[SUP]4[/SUP], Heijnen E[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUD:[/h] 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.
[h=4]MATERIALS AND METHODS:[/h] 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).
[h=4]RESULTS:[/h] 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%).
[h=4]CONCLUSION:[/h] 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.
Copyright ? 2018 by The Korean Society of Infectious Diseases and Korean Society for Chemotherapy.
[h=4]KEYWORDS:[/h] Adjuvant; Influenza; MF59; Older adults; Trivalent influenza vaccine
PMID: 30600653 DOI: 10.3947/ic.2018.50.4.301
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[h=1]Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD? and VANTAFLU? in South Korean Subjects Aged ≥65 Years.[/h] Yoo BW[SUP]1[/SUP], Kim CO[SUP]2[/SUP], Izu A[SUP]3[/SUP], Arora AK[SUP]4[/SUP], Heijnen E[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUD:[/h] 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.
[h=4]MATERIALS AND METHODS:[/h] 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).
[h=4]RESULTS:[/h] 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%).
[h=4]CONCLUSION:[/h] 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.
Copyright ? 2018 by The Korean Society of Infectious Diseases and Korean Society for Chemotherapy.
[h=4]KEYWORDS:[/h] Adjuvant; Influenza; MF59; Older adults; Trivalent influenza vaccine
PMID: 30600653 DOI: 10.3947/ic.2018.50.4.301
Free full text