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Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6-35 months

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Author(s)
Ui Yoon ChoiKi Hwan KimKyung Yil LeeJong-Hyun KimChun Soo KimByung Wook EunHwang Min KimDong Ho KimSong Eun SongDae Sun JoJin LeeSang Hyuk MaKwang Nam KimJin Han Kang
Keimyung Author(s)
Kim, Chun Soo
Department
Dept. of Pediatrics (소아청소년학)
Journal Title
Vaccine
Issued Date
2021
Volume
39
Issue
15
Keyword
Quadrivalent inactivated influenza vaccineChildrenImmunogenicitySafety
Abstract
The inactivated trivalent influenza vaccine (TIV) offers limited protection when two influenza B lineages co-circulate or when there is a vaccine mismatch (i.e., discordance in the predominant circulating B strain and WHO-recommended B strain). Inactivated quadrivalent influenza vaccine (QIV) may reduce the burden of influenza. Here, we report the results of a phase 3 clinical trial that evaluated the immunogenicity and safety of a novel QIV, GC3110A, in Korean children aged 6–35 months, which has been approved and is currently in use in Korea. The study involved two parts. In Part 1, the safety of GC3110A was evaluated in 10 subjects. After none of the subjects reported grade 3 adverse events (AEs), we proceeded to Part 2. Part 2 was a randomized, double-blind, multicenter phase 3 trial wherein we compared the immunogenicity and safety of GC3110A with those of a licensed control TIV. Immunogenicity was evaluated by measuring hemagglutination inhibition titers. The 200 participants enrolled in Part 2 were randomized in a 4:1 ratio to receive GC3110A or control TIV. The study vaccine group met both primary (i.e., the lower limit of 95% confidence interval [CI] of the seroconversion rate exceeds 40% for four strains) and secondary (i.e., the lower limit of 95% CI of the seroprotection rate exceeds 70% for four strains) immunogenicity endpoints. There was no significant between-group difference in the seroconversion rate, seroprotection rate, and geometric mean titer for the shared strains. However, the study vaccine group demonstrated significantly higher immunity for the additional strain B/Yamagata. In the safety analysis, there was no significant between-group difference in the proportion of participants with solicited local AEs, solicited systemic AEs, and unsolicited AEs. In conclusion, the results indicate that GC3110A has comparable immunogenicity and safety to those of TIV.
Keimyung Author(s)(Kor)
김천수
Publisher
School of Medicine (의과대학)
Citation
Ui Yoon Choi et al. (2021). Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6-35 months. Vaccine, 39(15), 2103–2109. doi: 10.1016/j.vaccine.2021.03.005
Type
Article
ISSN
0264-410X
Source
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0264410X21002735
DOI
10.1016/j.vaccine.2021.03.005
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43741
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Pediatrics (소아청소년학)
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