Immunogenicity and Safety of a Newly Developed Live Attenuated Varicella Vaccine in Healthy Children: A Multi-National, Randomized, Double-Blinded, Active-Controlled, Phase 3 Study
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Choi, Ui Yoon | - |
dc.contributor.author | Kim, Ki Hwan | - |
dc.contributor.author | Cho, Hye-Kyung | - |
dc.contributor.author | Kim, Dong Ho | - |
dc.contributor.author | Ma, Sang Hyuk | - |
dc.contributor.author | Choi, Young Youn | - |
dc.contributor.author | Kim, Chun Soo | - |
dc.contributor.author | Capeding, Maria Rosario | - |
dc.contributor.author | Kobashi, Ilya Angelica Rochin | - |
dc.contributor.author | Kim, Hun | - |
dc.contributor.author | Ryu, Ji Hwa | - |
dc.contributor.author | Lee, Su Jeen | - |
dc.contributor.author | Park, Ho Keun | - |
dc.contributor.author | Kim, Jong-Hyun | - |
dc.date.accessioned | 2023-12-28T01:30:18Z | - |
dc.date.available | 2023-12-28T01:30:18Z | - |
dc.date.issued | 2023-09 | - |
dc.identifier.issn | 2076-393X | - |
dc.identifier.issn | 2076-393X | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/89834 | - |
dc.description.abstract | Korean manufacturers have developed a new varicella vaccine, NBP608. This phase 3, randomized, double-blind, multicenter study aimed to compare the immunogenicity and safety of NBP608 in healthy children to those of VarivaxTM (control). Children aged 12 months to 12 years were randomized in a ratio of 1:1 to receive either NBP608 or the control vaccine. Serum samples were obtained before vaccination and within six to eight weeks after vaccination. In total, 499 participants (NBP608, n = 251; control, n = 248) were enrolled. The seroconversion rate (SCR) measured using a FAMA assay was 99.53% in the NBP608 group, and the lower limit of the 95% confidence interval (95% LCL) for the SCR difference (NBP608 minus the control) was 0.52%. This 95% LCL for the difference was higher than the specified non-inferiority margin of -15%. In an assessment using gpELISA, the SCR was 99.53% in the NBP608 group, and the 95% LCL for the SCR difference was 6.5%, which was higher than the specified non-inferiority margin of -15%. There were no significant differences between the NBP608 and control group with respect to the proportions of participants who demonstrated local and systemic solicited AEs. This study indicated that NBP608 had a clinically acceptable safety profile and was not immunologically inferior to VarivaxTM. | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | MDPI | - |
dc.title | Immunogenicity and Safety of a Newly Developed Live Attenuated Varicella Vaccine in Healthy Children: A Multi-National, Randomized, Double-Blinded, Active-Controlled, Phase 3 Study | - |
dc.type | Article | - |
dc.identifier.wosid | 001119280400001 | - |
dc.identifier.doi | 10.3390/vaccines11091416 | - |
dc.identifier.bibliographicCitation | VACCINES, v.11, no.9 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.scopusid | 2-s2.0-85172183860 | - |
dc.citation.title | VACCINES | - |
dc.citation.volume | 11 | - |
dc.citation.number | 9 | - |
dc.type.docType | Article | - |
dc.publisher.location | 스위스 | - |
dc.subject.keywordAuthor | varicella | - |
dc.subject.keywordAuthor | vaccine | - |
dc.subject.keywordAuthor | immunogenicity | - |
dc.subject.keywordAuthor | safety | - |
dc.subject.keywordAuthor | children | - |
dc.subject.keywordAuthor | clinical trial | - |
dc.subject.keywordPlus | LINKED-IMMUNOSORBENT-ASSAY | - |
dc.subject.keywordPlus | EVENT REPORTING SYSTEM | - |
dc.subject.keywordPlus | UNITED-STATES | - |
dc.subject.keywordPlus | PREVENTION | - |
dc.subject.keywordPlus | IMPACT | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea(13120)031-750-5114
COPYRIGHT 2020 Gachon University All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.