Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial
- Authors
- Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Lee, Soo Young; Kim, Hyun-Hee; Kim, Jong-Hyun; Lee, Kyung-Yil; Ma, Sang Hyuk; Park, Joon Soo; Kim, Hwang Min; Kim, Chun Soo; Kim, Dong Ho; Choi, Young Youn; Cha, Sung-Ho; Hong, Young Jin; Kang, Jin Han
- Issue Date
- 4-May-2015
- Publisher
- Landes Bioscience
- Keywords
- child; clinical trial; influenza; Republic of Korea; vaccine; AE, adverse event; CI, confidence interval; FDA, Food and Drug Administration; GMR, geometric mean titer ratio; GMT, geometric mean titer; HI, hemagglutination inhibition; USA, United States of America; WHO, World Health Organization
- Citation
- Human Vaccines and Immunotherapeutics, v.11, no.5, pp 1094 - 1101
- Pages
- 8
- Journal Title
- Human Vaccines and Immunotherapeutics
- Volume
- 11
- Number
- 5
- Start Page
- 1094
- End Page
- 1101
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/10646
- DOI
- 10.1080/21645515.2015.1017693
- ISSN
- 2164-5515
2164-554X
- 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.
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Collections - College of Medicine > Department of Pediatrics > 1. Journal Articles
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