A Randomized, Double-blind, Active-controlled Phase III Trial of a Cell Culture-derived Quadrivalent Inactivated Influenza Vaccine in Healthy South Korean Children and Adolescents 6 Months to 18 Years of Age
DC Field | Value | Language |
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dc.contributor.author | Eun, Byung Wook | - |
dc.contributor.author | Lee, Taek Jin | - |
dc.contributor.author | Lee, Jina | - |
dc.contributor.author | Kim, Ki Hwan | - |
dc.contributor.author | Kim, Dong Ho | - |
dc.contributor.author | Jo, Dae Sun | - |
dc.contributor.author | Shin, Sun Hee | - |
dc.contributor.author | Kim, Hun | - |
dc.contributor.author | Kim, Kyung-Ho | - |
dc.contributor.author | Kim, Yun-Kyung | - |
dc.date.accessioned | 2021-09-01T07:45:08Z | - |
dc.date.available | 2021-09-01T07:45:08Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2019-09 | - |
dc.identifier.issn | 0891-3668 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/63050 | - |
dc.description.abstract | Background: Cell culture-derived influenza vaccines have several important advantages over egg-based influenza vaccines. The quadrivalent influenza vaccine may offer broader protection against seasonal influenza than trivalent influenza vaccine by containing 1 more B strain. The purpose of this study was to evaluate the immunogenicity and safety of NBP607-QIV, a novel cell culture-derived inactivated quadrivalent influenza vaccine (cIIV4), in children and adolescents. Methods: This phase III, randomized, double-blind, multicenter trial in children/adolescents (6 mo to 18 yr) was conducted in South Korea during 2014-2015 season. Subjects were randomized 4:1 to receive either NBP607-QIV or control inactivated trivalent influenza vaccine. Hemagglutination inhibition antibody titers were assessed in prevaccination and 28 days postvaccination sera. Safety data were collected for up to 6 months postvaccination. Results: A total of 454 participants completed the study. Three-hundred sixty-six subjects received cIIV4 and 88 subjects received inactivated trivalent influenza vaccine. Overall, NBP607-QIV met the immunogenicity criteria of Committee for Medicinal Products for Human Use for each of the 4 strains. Between the NBP607-QIV and control groups, immunogenicity endpoints were comparable. Participants younger than 3 years of age had lower immunologic responses to 2 influenza B strains in both NBP607-QIV and control group. No deaths, vaccine-related serious adverse events (AEs) or withdrawals because of AEs were reported. The solicited AEs reported were generally of mild intensity. Conclusions: NBP607-QIV, a novel cIIV4, showed good immunogenicity to all 4 influenza strains and had tolerable safety profiles in children and adolescents. Moreover, NBP607-QIV was more immunogenic against influenza B compared with the control, an egg-based subunit vaccine. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | - |
dc.subject | IMMUNOGENICITY | - |
dc.subject | SAFETY | - |
dc.subject | MULTICENTER | - |
dc.subject | PROTECTION | - |
dc.subject | CORRELATE | - |
dc.subject | ADULTS | - |
dc.title | A Randomized, Double-blind, Active-controlled Phase III Trial of a Cell Culture-derived Quadrivalent Inactivated Influenza Vaccine in Healthy South Korean Children and Adolescents 6 Months to 18 Years of Age | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Yun-Kyung | - |
dc.identifier.doi | 10.1097/INF.0000000000002406 | - |
dc.identifier.scopusid | 2-s2.0-85071355776 | - |
dc.identifier.wosid | 000484343000004 | - |
dc.identifier.bibliographicCitation | PEDIATRIC INFECTIOUS DISEASE JOURNAL, v.38, no.9, pp.E209 - E215 | - |
dc.relation.isPartOf | PEDIATRIC INFECTIOUS DISEASE JOURNAL | - |
dc.citation.title | PEDIATRIC INFECTIOUS DISEASE JOURNAL | - |
dc.citation.volume | 38 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | E209 | - |
dc.citation.endPage | E215 | - |
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 | IMMUNOGENICITY | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | PROTECTION | - |
dc.subject.keywordPlus | CORRELATE | - |
dc.subject.keywordPlus | ADULTS | - |
dc.subject.keywordAuthor | influenza vaccines | - |
dc.subject.keywordAuthor | cell culture techniques | - |
dc.subject.keywordAuthor | influenza | - |
dc.subject.keywordAuthor | vaccines | - |
dc.subject.keywordAuthor | inactivated | - |
dc.subject.keywordAuthor | quadrivalent | - |
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