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.
Y. K. Kim,
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