tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2018 Mar 9. doi: 10.1097/INF.0000000000001973. [Epub ahead of print]
[h=1]A Randomized, Double-Blind, Active-Controlled Clinical Trial of a Cell Culture-Derived Inactivated Trivalent Influenza Vaccine (NBP607) in Healthy Children 6 Months Through 18 Years of Age.[/h] Oh CE[SUP]1[/SUP], Choi UY[SUP]2[/SUP], Eun BW[SUP]3[/SUP], Lee TJ[SUP]4[/SUP], Kim KH[SUP]5[/SUP], Kim DH[SUP]6[/SUP], Kim NH[SUP]7[/SUP], Jo DS[SUP]8[/SUP], Shin SH[SUP]9[/SUP], Kim KH[SUP]10[/SUP], Kim H[SUP]10[/SUP], Kim YK[SUP]11[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Although a number of cell culture-derived influenza vaccines have been approved for use in adults, there have been few clinical trials of cell culture-derived seasonal influenza vaccines for young children.
[h=4]METHODS:[/h] We conducted a randomized, double-blind phase III clinical trial to evaluate the safety and immunogenicity of a cell culture-derived subunit trivalent inactivated influenza vaccine (NBP607, SK Chemicals Co., Ltd., Seongnam, Korea) in healthy children aged 6 months through 18 years. Subjects were randomized to receive either a study vaccine or an egg-based control vaccine. Antibody levels were measured by the hemagglutination inhibition assay, using cell-derived antigens. Solicited adverse events were assessed for seven days after each injection. Serious adverse events were collected for 6 months after vaccination.
[h=4]RESULTS:[/h] A total of 374 participants completed the study. No deaths, vaccine-related serious adverse events, or withdrawals due to adverse events were reported. Rates of solicited and unsolicited adverse events were similar in two groups. Overall, NBP607 met the immunogenicity criteria of the Committee for Proprietary Medicinal Products for the three influenza strains. Between the NBP607 group and the control group, immunogenicity endpoints were comparable. Participants younger than three years of age had lower immunologic responses against the influenza B virus in both the NBP607 group and the control group.
[h=4]CONCLUSIONS:[/h] The immunogenicity and safety were comparable between the NBP607 group and the control group. NBP607 is well-tolerated and immunogenic in children aged 6 months through 18 years.
PMID: 29528914 DOI: 10.1097/INF.0000000000001973
[h=1]A Randomized, Double-Blind, Active-Controlled Clinical Trial of a Cell Culture-Derived Inactivated Trivalent Influenza Vaccine (NBP607) in Healthy Children 6 Months Through 18 Years of Age.[/h] Oh CE[SUP]1[/SUP], Choi UY[SUP]2[/SUP], Eun BW[SUP]3[/SUP], Lee TJ[SUP]4[/SUP], Kim KH[SUP]5[/SUP], Kim DH[SUP]6[/SUP], Kim NH[SUP]7[/SUP], Jo DS[SUP]8[/SUP], Shin SH[SUP]9[/SUP], Kim KH[SUP]10[/SUP], Kim H[SUP]10[/SUP], Kim YK[SUP]11[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Although a number of cell culture-derived influenza vaccines have been approved for use in adults, there have been few clinical trials of cell culture-derived seasonal influenza vaccines for young children.
[h=4]METHODS:[/h] We conducted a randomized, double-blind phase III clinical trial to evaluate the safety and immunogenicity of a cell culture-derived subunit trivalent inactivated influenza vaccine (NBP607, SK Chemicals Co., Ltd., Seongnam, Korea) in healthy children aged 6 months through 18 years. Subjects were randomized to receive either a study vaccine or an egg-based control vaccine. Antibody levels were measured by the hemagglutination inhibition assay, using cell-derived antigens. Solicited adverse events were assessed for seven days after each injection. Serious adverse events were collected for 6 months after vaccination.
[h=4]RESULTS:[/h] A total of 374 participants completed the study. No deaths, vaccine-related serious adverse events, or withdrawals due to adverse events were reported. Rates of solicited and unsolicited adverse events were similar in two groups. Overall, NBP607 met the immunogenicity criteria of the Committee for Proprietary Medicinal Products for the three influenza strains. Between the NBP607 group and the control group, immunogenicity endpoints were comparable. Participants younger than three years of age had lower immunologic responses against the influenza B virus in both the NBP607 group and the control group.
[h=4]CONCLUSIONS:[/h] The immunogenicity and safety were comparable between the NBP607 group and the control group. NBP607 is well-tolerated and immunogenic in children aged 6 months through 18 years.
PMID: 29528914 DOI: 10.1097/INF.0000000000001973