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
DC Field | Value | Language |
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dc.contributor.author | Oh, Chi Eun | - |
dc.contributor.author | Choi, Ui-Yoon | - |
dc.contributor.author | Eun, Byung Wook | - |
dc.contributor.author | Lee, Taek Jin | - |
dc.contributor.author | Kim, Ki Hwan | - |
dc.contributor.author | Kim, Dong Ho | - |
dc.contributor.author | Kim, Nam Hee | - |
dc.contributor.author | Jo, Dae Sun | - |
dc.contributor.author | Shin, Sun Hee | - |
dc.contributor.author | Kim, Kyung-Ho | - |
dc.contributor.author | Kim, Hun | - |
dc.contributor.author | Kim, Yun-Kyung | - |
dc.date.accessioned | 2021-09-02T10:39:16Z | - |
dc.date.available | 2021-09-02T10:39:16Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2018-06 | - |
dc.identifier.issn | 0891-3668 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/75055 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | - |
dc.subject | 6-TO 23-MONTH-OLD CHILDREN | - |
dc.subject | PHASE-III | - |
dc.subject | KOREAN CHILDREN | - |
dc.subject | IMMUNOGENICITY | - |
dc.subject | SAFETY | - |
dc.subject | MULTICENTER | - |
dc.subject | REACTOGENICITY | - |
dc.subject | ADOLESCENTS | - |
dc.subject | SPLIT | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Yun-Kyung | - |
dc.identifier.doi | 10.1097/INF.0000000000001973 | - |
dc.identifier.scopusid | 2-s2.0-85062169909 | - |
dc.identifier.wosid | 000433255600029 | - |
dc.identifier.bibliographicCitation | PEDIATRIC INFECTIOUS DISEASE JOURNAL, v.37, no.6, pp.605 - 611 | - |
dc.relation.isPartOf | PEDIATRIC INFECTIOUS DISEASE JOURNAL | - |
dc.citation.title | PEDIATRIC INFECTIOUS DISEASE JOURNAL | - |
dc.citation.volume | 37 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 605 | - |
dc.citation.endPage | 611 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalResearchArea | Infectious Diseases | - |
dc.relation.journalResearchArea | Pediatrics | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.relation.journalWebOfScienceCategory | Infectious Diseases | - |
dc.relation.journalWebOfScienceCategory | Pediatrics | - |
dc.subject.keywordPlus | 6-TO 23-MONTH-OLD CHILDREN | - |
dc.subject.keywordPlus | PHASE-III | - |
dc.subject.keywordPlus | KOREAN CHILDREN | - |
dc.subject.keywordPlus | IMMUNOGENICITY | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | REACTOGENICITY | - |
dc.subject.keywordPlus | ADOLESCENTS | - |
dc.subject.keywordPlus | SPLIT | - |
dc.subject.keywordAuthor | influenza vaccines | - |
dc.subject.keywordAuthor | cell culture techniques | - |
dc.subject.keywordAuthor | inactivated vaccines | - |
dc.subject.keywordAuthor | children | - |
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