Immunogenicity and safety of a split-virion quadrivalent influenza vaccine in adults 18–60 years of age in the Republic of Korea

Wonseok Choi, Ji Yun Noh, Jacob Lee, Jun Yong Choi, Jin Soo Lee, Moo Soo Kim, Hee Soo Kim, Joon Bang, Nathalie Lavis, Woo Joo Kim

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

VaxigripTetra® (Sanofi Pasteur, Lyon, France) is a quadrivalent split-virion inactivated influenza vaccine (IIV4) containing two B-lineage strains approved in the European Union and Taiwan in 2016 for individuals ≥ 3 years of age. Here, we describe an observer-blind, randomized, controlled, multicenter trial study evaluating the immunogenicity and safety of the Northern Hemisphere 2015–2016 formulations of IIV4 and the licensed split-virion trivalent inactivated influenza vaccine (IIV3) in the Republic of Korea (ClinicalTrials.gov no. NCT02550197). The study included 300 Korean adults 18–60 years of age randomized 2:1 to receive a single injection of IIV4 or IIV3. For each of the four vaccine strains in IIV4, 21 days after vaccination, geometric mean post-/pre-vaccination ratios of hemagglutination inhibition titers were ≥ 3.97. Seroconversion/significant increases rates were ≥ 40% for all but the A/H1N1 strain, for which the rate was 39.7%. Results were similar for the three strains in IIV3. For the additional B-lineage strain not in IIV3 (Victoria), hemagglutination inhibition antibody titers were higher for IIV4 than for IIV3. Solicited reactions and adverse events were similar between IIV4 and IIV3, and no serious adverse events or new safety signals were detected. These results confirm the robust immunogenicity and acceptable safety of IIV4 in adults 18–60 years of age and show that including a second B-lineage strain should provide broader protection against B-strain influenza without affecting vaccine safety or the immunogenicity of other three vaccine strains.

Original languageEnglish
Pages (from-to)1-6
Number of pages6
JournalHuman Vaccines and Immunotherapeutics
DOIs
Publication statusAccepted/In press - 2017 Nov 15

Fingerprint

Republic of Korea
Influenza Vaccines
Virion
Safety
Inactivated Vaccines
Vaccines
Hemagglutination
Multicenter Studies
Vaccination
Victoria
European Union
Taiwan
Human Influenza
France
Randomized Controlled Trials
Injections
Antibodies

Keywords

  • adults
  • inactivated influenza vaccine
  • quadrivalent influenza vaccine
  • Republic of Korea

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

Immunogenicity and safety of a split-virion quadrivalent influenza vaccine in adults 18–60 years of age in the Republic of Korea. / Choi, Wonseok; Noh, Ji Yun; Lee, Jacob; Choi, Jun Yong; Lee, Jin Soo; Kim, Moo Soo; Kim, Hee Soo; Bang, Joon; Lavis, Nathalie; Kim, Woo Joo.

In: Human Vaccines and Immunotherapeutics, 15.11.2017, p. 1-6.

Research output: Contribution to journalArticle

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