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

Chi Eun Oh, Ui Yoon Choi, Byung Wook Eun, Taek Jin Lee, Ki Hwan Kim, Dong Ho Kim, Nam Hee Kim, Dae Sun Jo, Sun Hee Shin, Kyung Ho Kim, Hun Kim, Yun Kyung Kim

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: 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. METHODS: 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 6 months of age 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 7 days after each injection. Serious adverse events were collected for 6 months after vaccination. RESULTS: A total of 374 participants completed the study. No deaths, vaccine-related serious adverse events or withdrawals resulting from adverse events were reported. Rates of solicited and unsolicited adverse events were similar in 2 groups. Overall, NBP607 met the immunogenicity criteria of the Committee for Proprietary Medicinal Products for the 3 influenza strains. Between the NBP607 group and the control group, immunogenicity endpoints were comparable. Participants younger than 3 years of age had lower immunologic responses against the influenza B virus in both the NBP607 group and the control group. CONCLUSIONS: The immunogenicity and safety were comparable between the NBP607 group and the control group. NBP607 is well tolerated and immunogenic in children 6 months of age through 18 years.

Original languageEnglish
Pages (from-to)605-611
Number of pages7
JournalThe Pediatric infectious disease journal
Volume37
Issue number6
DOIs
Publication statusPublished - 2018 Jun 1

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Influenza Vaccines
Controlled Clinical Trials
Vaccines
Cell Culture Techniques
Control Groups
Influenza B virus
Safety
Phase III Clinical Trials
Inactivated Vaccines
Hemagglutination
Korea
Human Influenza
Ovum
Vaccination
Clinical Trials
Antigens
Injections
Antibodies

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

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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. / Oh, Chi Eun; Choi, Ui Yoon; Eun, Byung Wook; Lee, Taek Jin; Kim, Ki Hwan; Kim, Dong Ho; Kim, Nam Hee; Jo, Dae Sun; Shin, Sun Hee; Kim, Kyung Ho; Kim, Hun; Kim, Yun Kyung.

In: The Pediatric infectious disease journal, Vol. 37, No. 6, 01.06.2018, p. 605-611.

Research output: Contribution to journalArticle

Oh, Chi Eun ; Choi, Ui Yoon ; Eun, Byung Wook ; Lee, Taek Jin ; Kim, Ki Hwan ; Kim, Dong Ho ; Kim, Nam Hee ; Jo, Dae Sun ; Shin, Sun Hee ; Kim, Kyung Ho ; Kim, Hun ; Kim, Yun Kyung. / 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. In: The Pediatric infectious disease journal. 2018 ; Vol. 37, No. 6. pp. 605-611.
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abstract = "BACKGROUND: 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. METHODS: 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 6 months of age 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 7 days after each injection. Serious adverse events were collected for 6 months after vaccination. RESULTS: A total of 374 participants completed the study. No deaths, vaccine-related serious adverse events or withdrawals resulting from adverse events were reported. Rates of solicited and unsolicited adverse events were similar in 2 groups. Overall, NBP607 met the immunogenicity criteria of the Committee for Proprietary Medicinal Products for the 3 influenza strains. Between the NBP607 group and the control group, immunogenicity endpoints were comparable. Participants younger than 3 years of age had lower immunologic responses against the influenza B virus in both the NBP607 group and the control group. CONCLUSIONS: The immunogenicity and safety were comparable between the NBP607 group and the control group. NBP607 is well tolerated and immunogenic in children 6 months of age through 18 years.",
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AU - Oh, Chi Eun

AU - Choi, Ui Yoon

AU - Eun, Byung Wook

AU - Lee, Taek Jin

AU - Kim, Ki Hwan

AU - Kim, Dong Ho

AU - Kim, Nam Hee

AU - Jo, Dae Sun

AU - Shin, Sun Hee

AU - Kim, Kyung Ho

AU - Kim, Hun

AU - Kim, Yun Kyung

PY - 2018/6/1

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N2 - BACKGROUND: 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. METHODS: 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 6 months of age 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 7 days after each injection. Serious adverse events were collected for 6 months after vaccination. RESULTS: A total of 374 participants completed the study. No deaths, vaccine-related serious adverse events or withdrawals resulting from adverse events were reported. Rates of solicited and unsolicited adverse events were similar in 2 groups. Overall, NBP607 met the immunogenicity criteria of the Committee for Proprietary Medicinal Products for the 3 influenza strains. Between the NBP607 group and the control group, immunogenicity endpoints were comparable. Participants younger than 3 years of age had lower immunologic responses against the influenza B virus in both the NBP607 group and the control group. CONCLUSIONS: The immunogenicity and safety were comparable between the NBP607 group and the control group. NBP607 is well tolerated and immunogenic in children 6 months of age through 18 years.

AB - BACKGROUND: 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. METHODS: 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 6 months of age 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 7 days after each injection. Serious adverse events were collected for 6 months after vaccination. RESULTS: A total of 374 participants completed the study. No deaths, vaccine-related serious adverse events or withdrawals resulting from adverse events were reported. Rates of solicited and unsolicited adverse events were similar in 2 groups. Overall, NBP607 met the immunogenicity criteria of the Committee for Proprietary Medicinal Products for the 3 influenza strains. Between the NBP607 group and the control group, immunogenicity endpoints were comparable. Participants younger than 3 years of age had lower immunologic responses against the influenza B virus in both the NBP607 group and the control group. CONCLUSIONS: The immunogenicity and safety were comparable between the NBP607 group and the control group. NBP607 is well tolerated and immunogenic in children 6 months of age through 18 years.

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