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, Won Suk Choi, Hee Jin Cheong, Woo Joo Kim

    Research output: Contribution to journalArticlepeer-review

    2 Citations (Scopus)

    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
    Pages (from-to)710-716
    Number of pages7
    JournalHuman Vaccines and Immunotherapeutics
    Volume15
    Issue number3
    DOIs
    Publication statusPublished - 2019 Mar 4

    Keywords

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

    ASJC Scopus subject areas

    • Immunology and Allergy
    • Immunology
    • Pharmacology

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