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Safety and immunogenicity of an inactivated split-virus influenza A/H1N1 vaccine in healthy children from 6 months to < 18 years of age: A prospective, open-label, multi-center trial

Cited 32 time in Web of Science Cited 33 time in Scopus
Authors

Oh, Chi-Eun; Lee, Jina; Kang, Jin-Han; Hong, Young-Jin; Cheong, Hee-Jin; Kim, Sang-Hoon; Lee, Hoan-Jong; Ahn, Young-Joo; Kim, Yun-Kyung

Issue Date
2010-08-16
Publisher
ELSEVIER SCI LTD
Citation
VACCINE; Vol.28 36; 5857-5863
Keywords
H1N1 virusPandemicInfluenza vaccine
Abstract
This study was conducted to determine the immunogenicity and safety of an inactivated split-virus influenza A/H1N1 vaccine in healthy Korean children from 6 months to <18 years of age. The immunization schedule consisted of two vaccinations, 21 days apart. The unadjuvanted vaccine contained 7.5 mu g (subjects 6 months to <3 years of age) or 15 mu g (subjects 3 to <18 years of age) of hemagglutinin antigen per dose. A total of 251 subjects were enrolled and 248 and 242 subjects, respectively, were included in the post-first dose and post-second dose immunogenicity evaluations conducted on a per protocol basis. By day 21, after the first dose, hemagglutination-inhibition titers of 1:40 or more were observed in 5.9% of subjects 6 months to <3 years of age, 34.9% of subjects 3 to <9 years of age and 81.4% of subjects 9-18 years of age. By day 21 after the second dose, the titer had been achieved 55.9%, 69.5% and 90.5%, respectively. No vaccination-related serious adverse events were observed. A single 15-mu g dose of vaccine was highly immunogenic in subjects equal to or more than 9 years of age. However, a two-dose regimen is needed to produce potentially protective antibody titers in younger children. (C) 2010 Elsevier Ltd. All rights reserved.
ISSN
0264-410X
Language
English
URI
https://hdl.handle.net/10371/76999
DOI
https://doi.org/10.1016/j.vaccine.2010.06.060
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Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Pediatrics (소아과학전공)Journal Papers (저널논문_소아과학전공)
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