Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years.
- Author:
Byung Wook YOO
1
;
Chang Oh KIM
;
Allen IZU
;
Ashwani Kumar ARORA
;
Esther HEIJNEN
Author Information
- Publication Type:Multicenter Study ; Original Article
- Keywords: Influenza; Older adults; Trivalent influenza vaccine; Adjuvant; MF59
- MeSH: Adult; Fatigue; Humans; Influenza Vaccines*; Influenza, Human*; Korea; Mortality; Myalgia; Vaccination
- From:Infection and Chemotherapy 2018;50(4):301-310
- CountryRepublic of Korea
- Language:English
- Abstract: 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.
