tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2019 Jul 16. doi: 10.1097/INF.0000000000002406. [Epub ahead of print]
[h=1]A Randomized, Double-blind, Active-controlled Phase III Trial of a Cell Culture-derived Quadrivalent Inactivated Influenza Vaccine in Healthy South Korean Children and Adolescents 6 Months to 18 Years of Age.[/h] Eun BW[SUP]1[/SUP], Lee TJ[SUP]2[/SUP], Lee J[SUP]3[/SUP], Kim KH[SUP]4[/SUP], Kim DH[SUP]5[/SUP], Jo DS[SUP]6[/SUP], Shin SH[SUP]7[/SUP], Kim H[SUP]8[/SUP], Kim KH[SUP]8[/SUP], Kim YK[SUP]9[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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 to the control, an egg-based subunit vaccine.
PMID: 31335572 DOI: 10.1097/INF.0000000000002406
[h=1]A Randomized, Double-blind, Active-controlled Phase III Trial of a Cell Culture-derived Quadrivalent Inactivated Influenza Vaccine in Healthy South Korean Children and Adolescents 6 Months to 18 Years of Age.[/h] Eun BW[SUP]1[/SUP], Lee TJ[SUP]2[/SUP], Lee J[SUP]3[/SUP], Kim KH[SUP]4[/SUP], Kim DH[SUP]5[/SUP], Jo DS[SUP]6[/SUP], Shin SH[SUP]7[/SUP], Kim H[SUP]8[/SUP], Kim KH[SUP]8[/SUP], Kim YK[SUP]9[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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 to the control, an egg-based subunit vaccine.
PMID: 31335572 DOI: 10.1097/INF.0000000000002406