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
- Authors
- 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
- Issue Date
- Jun-2018
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS
- Keywords
- influenza vaccines; cell culture techniques; inactivated vaccines; children
- Citation
- PEDIATRIC INFECTIOUS DISEASE JOURNAL, v.37, no.6, pp.605 - 611
- Indexed
- SCIE
SCOPUS
- Journal Title
- PEDIATRIC INFECTIOUS DISEASE JOURNAL
- Volume
- 37
- Number
- 6
- Start Page
- 605
- End Page
- 611
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/75055
- DOI
- 10.1097/INF.0000000000001973
- ISSN
- 0891-3668
- 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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Collections - College of Medicine > Department of Medical Science > 1. Journal Articles
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