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Pediatr Infect Dis J. 2018 Jun;37(6):605-611. doi: 10.1097/INF.0000000000001973.

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.

Author information

1
From the Division of Infectious Diseases, Department of Pediatrics, Kosin University College of Medicine, Busan, Republic of Korea.
2
Division of Infectious Diseases, Department of Pediatrics, St. Paul's Hospital, Catholic University of Korea, Seoul, Republic of Korea.
3
Division of Infectious Diseases, Department of Pediatrics, Euilgi University College of Medicine, Seoul, Republic of Korea.
4
Division of Infectious Diseases, Department of Pediatrics, Cha College of Medicine, Seongnam, Republic of Korea.
5
Division of Infectious Diseases, Department of Pediatrics, Catholic University of Korea, Incheon Hospital, Incheon, Republic of Korea.
6
Division of Infectious Diseases, Department of Pediatrics, Korea Institute of Radiological Medical Sciences, Seoul, Republic of Korea.
7
Division of Infectious Diseases, Department of Pediatrics, Inje University College of Medicine, Busan, Republic of Korea.
8
Division of Infectious Diseases, Department of Pediatrics, Chonbuk National University Children's Hospital, Jeonju, Republic of Korea.
9
Division of Infectious Diseases, Department of Pediatrics, Hallym University College of Medicine, Seoul, Republic of Korea.
10
Life Science Research Institute, SK Chemicals Co., Ltd., Seongnam, Republic of Korea.
11
Division of Infectious Diseases, Department of Pediatrics, Korea University College of Medicine, Seoul, Republic of Korea.

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.

PMID:
29528914
DOI:
10.1097/INF.0000000000001973
[Indexed for MEDLINE]

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