763. Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV) in South Korean children and adolescents: A randomized, double-blind, multi-center, phase 3 clinical trial
Session: Poster Abstract Session: Vaccines: Pediatric
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • IDWeek2016_Session77_763.pdf (593.0 kB)
  • Background: Cell culture-derived influenza vaccines have several important advantages over egg-based influenza vaccines and inactivated quadrivalent influenza vaccine (IIV4) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3) by containing one more B strain. This study examined the immunogenicity and safety of a cell culture-derived IIV4 candidate vaccine in children and adolescents.

    Methods: This phase III, randomized, double-blind, multicenter trial in children/adolescents (6 month through 18 years) was conducted in South Korea. Children/adolescents were randomized 4:1 to receive one of novel cell culture-derived, subunit, IIV4 (NBP607-QIV, SK Chemicals, Seongnam, Korea) or licensed IIV3 (Agrippal®S1, Novartis Vaccines and Diagnostics Srl, Siena, Italy). Hemagglutination inhibition antibody titers were assessed pre-vaccination and 28 days post-vaccination. Safety data were collected for up to 6 months post-vaccination.

    Results: 366 children/adolescents received IIV4, and 88 children/adolescents received IIV3. Overall, NBP607-QIV met the immunogenicity criteria of Committee for Medicinal Products for Human Use for each of the 4 strains. Between the NBP607-QIV and control groups, mmunogenicity endpoints were comparable. Participants younger than 3 years of age had lower immunologic responses against 2 influenza B strains in both NBP607-QIV and control group. No deaths, vaccine-related SAEs, or withdrawals because of adverse events were reported. The solicited adverse events reported were generally of mild intensity.

    Conclusion: NBP607-QIV, a novel cell culture-derived IIV4, showed good immunogenicity to all 4 influenza strains and had tolerable safety profiles in children and adolescents. Moreover, NBP607-QIV was more immunogenic against influenza B compared to the control, an egg-based subunit vaccine.

    Yun-Kyung Kim, MD, PhD, Department of Pediatrics, Korea University, Ansan City, Gyeonggi-Do, South Korea, Byung Wook Eun, MD, PhD, Pediatrics, Nowon Euilgi hospital, SEOUL, Korea, The Republic of, Taek Jin Lee, M.D., Pediatrics, Cha College of Medicine, Seongnam, Korea, The Republic of, Jina Lee, MD, PhD, Department of Pediatrics, University of Ulsan College of Medicine and Asan Medical Center, Seoul, South Korea, Ki Hwan Kim, M.D., Pediatrics, Catholic university of Korea Incheon St. Mary`s Hospital, Incheon, Korea, The Republic of, Dong Ho Kim, MD, Department of Pediatrics, Korea Cancer Center Hosptal, Seoul, South Korea, Dae Sun Jo, M.D., Ph.D., Pediatrics, Chonbuk National University Children's Hospital, Jeonju, Korea, The Republic of and Sun-Hee Shin, MD, Pediatrics, Hallym Univ Coll of Med, Seoul, Korea, Republic of

    Disclosures:

    Y. K. Kim, SK chemicals: Investigator and Scientific Advisor , Consulting fee and Research grant

    B. W. Eun, Sk chemicals: Investigator and Scientific Advisor , Consulting fee and Research grant

    T. J. Lee, Sk chemicals: Investigator , Research grant

    J. Lee, Sk chemicals: Investigator , Research grant

    K. H. Kim, Sk chemicals: Investigator , Research grant

    D. H. Kim, Sk chemicals: Investigator , Research grant

    D. S. Jo, Sk chemicals: Investigator and Scientific Advisor , Consulting fee and Research grant

    S. H. Shin, Sk chemicals: Investigator , Research grant

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