title: 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.
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 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.
authors: Department of Pediatrics, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
authors: Jin-Han
authors: JH
authors: Kang
authors: Chi-Eun
authors: CE
authors: Oh
authors: Jina
authors: J
authors: Lee
authors: Soo-Young
authors: SY
authors: Lee
authors: Sung-Ho
authors: SH
authors: Cha
authors: Dong Soo
authors: DS
authors: Kim
authors: Hyun-Hee
authors: HH
authors: Kim
authors: Jung-Hyun
authors: JH
authors: Lee
authors: Jin-Tack
authors: JT
authors: Kim
authors: Sang-Hyuk
authors: SH
authors: Ma
authors: Young-Jin
authors: YJ
authors: Hong
authors: Hee Jin
authors: HJ
authors: Cheong
authors: Hoan-Jong
authors: HJ
authors: Lee
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology*; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D056910:Republic of Korea; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated