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.
10.3346/jkms.2011.26.11.1421
- Author:
Jin Han KANG
1
;
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
Author Information
1. Department of Pediatrics, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
- Publication Type:Original Article ; Clinical Trial, Phase III ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Influenza Vaccines;
Child;
Immunogenicity;
Safety
- MeSH:
Adolescent;
Antibodies, Viral/*blood;
Child;
Child, Preschool;
Double-Blind Method;
Female;
Humans;
Infant;
Influenza A Virus, H1N1 Subtype/*immunology;
Influenza A Virus, H3N2 Subtype/*immunology;
Influenza B virus/*immunology;
Influenza Vaccines/*adverse effects/*immunology;
Male;
Republic of Korea;
Vaccination;
Vaccines, Inactivated/adverse effects/immunology
- From:Journal of Korean Medical Science
2011;26(11):1421-1427
- CountryRepublic of Korea
- Language:English
-
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.
