Infect Chemother.  2018 Dec;50(4):301-310. 10.3947/ic.2018.50.4.301.

Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years

Affiliations
  • 1Department of Family Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.
  • 2Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • 3Novartis Vaccines, Seqirus USA Inc., Cambridge, MA, USA.
  • 4Novartis Vaccines, Seqirus S.r.l. Siena, Italy.
  • 5Novartis Vaccines, Seqirus Netherlands, Amsterdam, The Netherlands. estherheijnen@gmail.com

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.

Keyword

Influenza; Older adults; Trivalent influenza vaccine; Adjuvant; MF59

MeSH Terms

Adult
Fatigue
Humans
Influenza Vaccines*
Influenza, Human*
Korea
Mortality
Myalgia
Vaccination
Influenza Vaccines

Figure

  • Figure 1 Study subject disposition.

  • Figure 2 Solicited local adverse events (AEs) reported by subjects between 6 hours and day 4 after vaccination (safety set). aSevere tenderness and pain were reported by a single subject in FLUAD® group.

  • Figure 3 Solicited systemic adverse events (AEs) reported by subjects between 6 hours and day 4 after vaccination (safety set). aSevere fatigue was reported by two subjects in FLUAD® group.


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