Background: Cell culture-derived influenza vaccines have several important advantages over egg-based influenza vaccines. The quadrivalent influenza vaccine may offer broader protection against seasonal influenza than trivalent influenza vaccine by containing 1 more B strain. The purpose of this study was to evaluate the immunogenicity and safety of NBP607-QIV, a novel cell culture-derived inactivated quadrivalent influenza vaccine (cIIV4), in children and adolescents. Methods: This phase III, randomized, double-blind, multicenter trial in children/adolescents (6 mo to 18 yr) was conducted in South Korea during 2014-2015 season. Subjects were randomized 4:1 to receive either NBP607-QIV or control inactivated trivalent influenza vaccine. Hemagglutination inhibition antibody titers were assessed in prevaccination and 28 days postvaccination sera. Safety data were collected for up to 6 months postvaccination. Results: A total of 454 participants completed the study. Three-hundred sixty-six subjects received cIIV4 and 88 subjects received inactivated trivalent influenza vaccine. 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, immunogenicity endpoints were comparable. Participants younger than 3 years of age had lower immunologic responses to 2 influenza B strains in both NBP607-QIV and control group. No deaths, vaccine-related serious adverse events (AEs) or withdrawals because of AEs were reported. The solicited AEs reported were generally of mild intensity. Conclusions: NBP607-QIV, a novel cIIV4, 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 with the control, an egg-based subunit vaccine.
Bibliographical noteFunding Information:
H.K. and K-H.K. who are employees of SK Bioscience Corporation. All authors have submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. This work was supported by the SK Bioscience Corporation, Seongnam, Republic of Korea (SK Biosci-ence was spun off from SK Chemicals Corporation on July 2, 2018). The other authors have no conflicts of interest to disclose.
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
- cell culture techniques
- influenza vaccines
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Microbiology (medical)
- Infectious Diseases