PMID- 30600653
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220330
IS  - 2093-2340 (Print)
IS  - 2092-6448 (Electronic)
IS  - 1598-8112 (Linking)
VI  - 50
IP  - 4
DP  - 2018 Dec
TI  - Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza 
      Vaccines FLUAD(R) and VANTAFLU(R) in South Korean Subjects Aged >/=65 Years.
PG  - 301-310
LID - 10.3947/ic.2018.50.4.301 [doi]
AB  - 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(R) and VANTAFLU(R), 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(R), n = 389; VANTAFLU(R), 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(R) or VANTAFLU(R) had acceptable 
      safety profiles in older adults (aged >/=65 years) in South Korea.
CI  - Copyright (c) 2018 by The Korean Society of Infectious Diseases and Korean Society 
      for Chemotherapy.
FAU - Yoo, Byung Wook
AU  - Yoo BW
AUID- ORCID: 0000-0002-8753-9660
AD  - Department of Family Medicine, Soonchunhyang University Seoul Hospital, Seoul, 
      Korea.
FAU - Kim, Chang Oh
AU  - Kim CO
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Izu, Allen
AU  - Izu A
AD  - Novartis Vaccines, Seqirus USA Inc., Cambridge, MA, USA.
FAU - Arora, Ashwani Kumar
AU  - Arora AK
AD  - Novartis Vaccines, Seqirus S.r.l. Siena, Italy.
FAU - Heijnen, Esther
AU  - Heijnen E
AUID- ORCID: 0000-0002-1685-8787
AD  - Novartis Vaccines, Seqirus Netherlands, Amsterdam, The Netherlands. 
      estherheijnen@gmail.com.
LA  - eng
GR  - Novartis Vaccines/
PT  - Journal Article
PL  - Korea (South)
TA  - Infect Chemother
JT  - Infection & chemotherapy
JID - 101531537
PMC - PMC6312896
OTO - NOTNLM
OT  - Adjuvant
OT  - Influenza
OT  - MF59
OT  - Older adults
OT  - Trivalent influenza vaccine
COIS- 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.
EDAT- 2019/01/03 06:00
MHDA- 2019/01/03 06:01
PMCR- 2018/12/01
CRDT- 2019/01/03 06:00
PHST- 2018/06/21 00:00 [received]
PHST- 2018/09/23 00:00 [accepted]
PHST- 2019/01/03 06:00 [entrez]
PHST- 2019/01/03 06:00 [pubmed]
PHST- 2019/01/03 06:01 [medline]
PHST- 2018/12/01 00:00 [pmc-release]
AID - 50.301 [pii]
AID - 10.3947/ic.2018.50.4.301 [doi]
PST - ppublish
SO  - Infect Chemother. 2018 Dec;50(4):301-310. doi: 10.3947/ic.2018.50.4.301.