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Infect Chemother. 2018 Dec;50(4):301-310. doi: 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.

Author information

1
Department of Family Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.
2
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
3
Novartis Vaccines, Seqirus USA Inc., Cambridge, MA, USA.
4
Novartis Vaccines, Seqirus S.r.l. Siena, Italy.
5
Novartis 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.

KEYWORDS:

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

Conflict of interest statement

BWY, COK, and AI report fees from Novartis and non-financial support for study conduct by Novartis. AKA and EH were employed by the sponsor Novartis at the time of study conduct, and Novartis Influenza Vaccines was acquired by the CSL group on July, 31, 2015, and is currently operating as Seqirus.

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