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Abstract

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Article in Japanese

Original Article

Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults in Japan

Naoaki Watanabea  Nobuharu Ohshimaa  Hideaki Nagaia  Takafumi Katoa  Minako Saitoa  Ayaka Igarashib  Maho Suzukawab  Masahiro Kawashimaa  Isao Asarib  Hirotoshi Matsuia 

aCenter for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital
bDepartment of Clinical Research, National Hospital Organization Tokyo National Hospital

ABSTRACT

An inactivated quadrivalent influenza vaccine (QIV) was licensed in Japan in the 2015/2016 influenza season. In this prospective study, we assessed the immunogenicity and safety of the QIV. The study included 78 subjects aged 23–60 years. Immunogenicity was assessed using hemagglutination-inhibition assays. Reactogenicity was assessed for 6 days after vaccination, and unsolicited adverse events were assessed for 14 days after vaccination. The seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean titer ratio (GMR) were: 7.7%, 80.8%, and 1.4, respectively, for the A/H1N1pdm09 strain; 76.9%, 98.7%, and 6.6, respectively, for the A/H3N2 strain; 2.6%, 67.9%, and 1.4, respectively, for the B/Yamagata strain, and 3.9%, 29.5%, and 1.3, respectively for the B/Victoria strain. Therefore A/H3N2 met all the European Medicines Agency (EMA) criteria, A/H1N1pdm09 met only the SPR, and B/Victoria and B/Yamagata met none of the criteria. The most frequent adverse event was erythema/swelling (80.8%), followed by pain (73.1%), malaise (16.7%), pruritus (12.8%), myalgia (5.1%), headache (3.8%), arthralgia (3.8%), fever (1.3%), and nausea (1.3%). Our trial demonstrated that the QIV was well tolerated, but that some strains are not immunogenic, and suggests that quality improvement needs to be implemented for the QIV.

KEYWORDS

Quadrivalent influenza vaccine  Immunogenicity  Safety 

Received 22 May 2017 / Accepted 9 Apr 2018

AJRS, 7(4): 197-203, 2018

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