Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial
- Abstract
- A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8-67.2), 53.4% (95% CI: 48.1-58.7), and 54.9% (95% CI: 48.1-60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6-97.3), 93.8% (95% CI: 91.2-96.4), and 95.3% (95% CI: 93.0-97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective.
- All Author(s)
- S. B. Han
; J. W. Rhim
; H. J. Shin
; S. Y. Lee
; H. H. Kim
; J. H. Kim
; K. Y. Lee
; S. H. Ma
; J. S. Park
; H. M. Kim
; C. S. Kim
; D. H. Kim
; Y. Y. Choi
; S. H. Cha
; Y. J. Hong
; J. H. Kang
- Issued Date
- 2015
- Type
- Article
- Keyword
- child; clinical trial; influenza; Republic of Korea; vaccine
- ISSN
- 2164-5515
- Citation Title
- Human Vaccines & Immunotherapeutics
- Citation Volume
- 11
- Citation Number
- 5
- Citation Start Page
- 1094
- Citation End Page
- 1101
- Language(ISO)
- eng
- DOI
- 10.1080/21645515.2015.1017693
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/3018
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