Safety and immunogenicity of a new trivalent inactivated split-virus influenza vaccine in healthy korean children: A randomized, double-blinded, active-controlled, Phase III study

Jin Han Kang, Chi Eun Oh, Jina Lee, Soo Young Lee, Sung Ho Cha, Dong Soo Kim, Hyun Hee Kim, Jung Hyun Lee, Jin Tack Kim, Sang Hyuk Ma, Young Jin Hong, Hee Jin Cheong, Hoan Jong Lee

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7 Citations (Scopus)

Abstract

We report results of a randomized, double-blinded, active-controlled, phase III study conducted to evaluate the immunogenicity and safety of a new trivalent inactivated splitvirus influenza vaccine (GC501) manufactured by the Green Cross Corporation in Korea. A total of 283 healthy children aged 6 months to < 18 yr were randomized to receive either GC501 or control. Of the GC501 recipients, seroconversion occurred in 48.5% for A/H1N1, 67.7% for A/H3N2 and 52% for influenza B. The proportion of subjects who had postvaccination hemagglutination-inhibition titers of 1:40 or greater was 90.7% for A/H1N1, 86.8% for A/H3N2 and 82.4% for influenza B in the GC501 recipients. No serious adverse events related to vaccination, or withdrawals because of adverse events were reported. The majority of solicited adverse events were mild in intensity. GC501 vaccine has good tolerability and favorable immunogenicity in children aged 6 months to < 18 yr. The addition of one more brand of influenza vaccine may allow for better global accessibility of vaccine for epidemics or future pandemics.

Original languageEnglish
Pages (from-to)1421-1427
Number of pages7
JournalJournal of Korean medical science
Volume26
Issue number11
DOIs
Publication statusPublished - 2011 Nov

Keywords

  • Child
  • Immunogenicity
  • Influenza vaccines
  • Safety

ASJC Scopus subject areas

  • Medicine(all)

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    Kang, J. H., Oh, C. E., Lee, J., Lee, S. Y., Cha, S. H., Kim, D. S., Kim, H. H., Lee, J. H., Kim, J. T., Ma, S. H., Hong, Y. J., Cheong, H. J., & Lee, H. J. (2011). Safety and immunogenicity of a new trivalent inactivated split-virus influenza vaccine in healthy korean children: A randomized, double-blinded, active-controlled, Phase III study. Journal of Korean medical science, 26(11), 1421-1427. https://doi.org/10.3346/jkms.2011.26.11.1421