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KMID : 0191120110260111421
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Journal of Korean Medical Science
2011 Volume.26 No. 11 p.1421 ~ p.1427
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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
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Kang Jin-Han
Oh Chi-Eun
Lee Ji-Na
Lee Soo-Young
Cha Sung-Ho
Kim Dong-Soo
Kim Hyun-Hee
Lee Jung-Hyun
Kim Jin-Tack
Ma Sang-Hyuk
Hong Young-Jin
Cheong Hee-Jin
Lee Hoan-Jong
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Abstract
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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 split-virus 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 post-vaccination 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.
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KEYWORD
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Influenza Vaccines, Child, Immunogenicity, Safety
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