Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects
DC Field | Value | Language |
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dc.contributor.author | Choi, Won Suk | - |
dc.contributor.author | Noh, Ji Yun | - |
dc.contributor.author | Song, Joon Young | - |
dc.contributor.author | Cheong, Hee Jin | - |
dc.contributor.author | Wie, Seong-Heon | - |
dc.contributor.author | Lee, Jin Soo | - |
dc.contributor.author | Lee, Jacob | - |
dc.contributor.author | Kim, Shin-Woo | - |
dc.contributor.author | Jeong, Hye Won | - |
dc.contributor.author | Jung, Sook-In | - |
dc.contributor.author | Kim, Yeon-Sook | - |
dc.contributor.author | Woo, Heung Jeong | - |
dc.contributor.author | Kim, Kyung Ho | - |
dc.contributor.author | Kim, Hun | - |
dc.contributor.author | Kim, Woo Joo | - |
dc.date.accessioned | 2021-09-03T15:04:42Z | - |
dc.date.available | 2021-09-03T15:04:42Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 2164-5515 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/86338 | - |
dc.description.abstract | Background: The influenza B virus has two lineages; Yamagata and Victoria. The two lineages are antigenically distinct and it is difficult to expect cross-protection between the lineages. Actually, the mismatch between circulating influenza B viruses and vaccine strains has been occurred frequently. The cell-culture system for the production of influenza vaccine can contribute to improve vaccine strain selection and expand vaccine supplies. We investigated the immunogenicity and safety of cell culture-derived quadrivalent inactivated influenza vaccine (NBP607-QIV) in adults and elderly subjects. Methods: A randomized controlled phase III trial was undertaken in 10 university hospitals in the Republic of Korea (Clinical trial Number-NCT02467842). Adults (aged 19-59 years) and elderly subjects (aged >= 60 years) were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine-Yamagata (NBP607-Y) and cell culture-based trivalent inactivated influenza vaccine-Victoria (NBP607-V). Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition assay. Safety was assessed for 6 months post-vaccination: solicited adverse events (AEs) for 7 days, unsolicited AEs for 21 days and serious adverse events (SAEs) for 6 months. AEs were sub-classified as adverse drug reactions (ADRs) according to the causality. Results: A total of 1,503 participants were randomly assigned to NBP607-QIV (n = 752), NBP607-Y (n = 373) and NBP607-V (n = 378). The seroconversion rates of NBP607-QIV were 52.4%, 51.2%, 43.7% and 55.8% against A/H1N1, A/H3N2, B/Yamagata and B/Victoria, respectively. Non-inferiority against shared strains and superiority against alternate-lineage B strains were demonstrated for NBP607-QIV vs. NBP607-Y and NBP607-V. A total of 730 reactions occurred in 324 (43.1%) subjects of NBP607-QIV group. Majority of ADRs was solicited (99.2%) and mild (90.3%) in intensity. In adults (aged 19-59 years), solicited local AEs were slightly more frequent in NBP607-QIV group than NBP607-Y or NBP607-V group (40.9%, 33.4% and 32.5%, respectively). One SAE was observed among NBP607-QIV group, which was considered to be unrelated to the study vaccine within 3 weeks of vaccination and no vaccine-related SAEs were reported up to 6 months after vaccination. Conclusions: NBP607-QIV is a safe, well-tolerated and immunogenic influenza vaccine in Korean adults and elderly subjects. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | TAYLOR & FRANCIS INC | - |
dc.subject | SEASONAL INFLUENZA | - |
dc.title | Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Choi, Won Suk | - |
dc.contributor.affiliatedAuthor | Noh, Ji Yun | - |
dc.contributor.affiliatedAuthor | Song, Joon Young | - |
dc.contributor.affiliatedAuthor | Cheong, Hee Jin | - |
dc.contributor.affiliatedAuthor | Kim, Woo Joo | - |
dc.identifier.doi | 10.1080/21645515.2017.1297351 | - |
dc.identifier.scopusid | 2-s2.0-85017499974 | - |
dc.identifier.wosid | 000405627900024 | - |
dc.identifier.bibliographicCitation | HUMAN VACCINES & IMMUNOTHERAPEUTICS, v.13, no.7, pp.1653 - 1660 | - |
dc.relation.isPartOf | HUMAN VACCINES & IMMUNOTHERAPEUTICS | - |
dc.citation.title | HUMAN VACCINES & IMMUNOTHERAPEUTICS | - |
dc.citation.volume | 13 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 1653 | - |
dc.citation.endPage | 1660 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Biotechnology & Applied Microbiology | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalWebOfScienceCategory | Biotechnology & Applied Microbiology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.subject.keywordPlus | SEASONAL INFLUENZA | - |
dc.subject.keywordAuthor | cell culture techniques | - |
dc.subject.keywordAuthor | clinical trial | - |
dc.subject.keywordAuthor | human | - |
dc.subject.keywordAuthor | inactivated | - |
dc.subject.keywordAuthor | influenza B virus | - |
dc.subject.keywordAuthor | influenza vaccine | - |
dc.subject.keywordAuthor | vaccine | - |
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