Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains: A phase Ⅲ randomized clinical trial in adults

Joon-Young Song, Jacob Lee, Heung Jeong Woo, Seong Heon Wie, Jin Soo Lee, Shin Woo Kim, Tae Hyong Kim, Sook In Jung, Ji Yun Noh, Wonseok Choi, Hee-Jin Cheong, Woo Joo Kim

Research output: Contribution to journalArticle

Abstract

Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have been co-circulating globally since the mid-1980s. The quadrivalent influenza vaccine (QIV) may provide better protection against unpredictable B strains. We conducted a randomized, double-blind, phase III trial to evaluate the immunogenicity and safety of an egg-based inactivated, split-virion QIV (GC3110A). Subjects aged ≥ 19 years were randomized 2:1:1 to be vaccinated with QIV- GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage strain (TIV-Yamagata), or TIV containing the Victoria lineage strain (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days post-vaccination. Solicited/unsolicited adverse events (AEs) were assessed within 21 days after vaccination, while serious AEs were reported up to six months after vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and the difference of seroconversion rate. The safety profiles of QIV-GC3110A were consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, and comparable to strain-matched TIV.

Original languageEnglish
JournalHuman Vaccines and Immunotherapeutics
DOIs
Publication statusAccepted/In press - 2018 Jan 1

Keywords

  • Inactivated quadrivalent influenza vaccine
  • Influenza B
  • victoria lineage
  • yamagata lineage

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

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