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- Title
Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years.
- Authors
Byung Wook Yoo; Chang Oh Kim; Allen Izu; Arora, Ashwani Kumar; Esther Heijnen
- 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 VANTAPLU®, 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.
- Subjects
SOUTH Korea; INFLUENZA vaccines; INFLUENZA; DISEASES; PAIN; MORTALITY; ADULTS
- Publication
Infection & Chemotherapy, 2018, Vol 50, Issue 4, p301
- ISSN
2093-2340
- Publication type
Article
- DOI
10.3947/ic.2018.50.4.301