title: Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial.
abstract: A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8-67.2), 53.4% (95% CI: 48.1-58.7), and 54.9% (95% CI: 48.1-60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6-97.3), 93.8% (95% CI: 91.2-96.4), and 95.3% (95% CI: 93.0-97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective.
authors: a Department of Pediatrics; The Catholic University of Korea College of Medicine ; Seoul , Republic of Korea.
authors: Seung Beom
authors: SB
authors: Han
authors: Jung-Woo
authors: JW
authors: Rhim
authors: Hye Jo
authors: HJ
authors: Shin
authors: Soo Young
authors: SY
authors: Lee
authors: Hyun-Hee
authors: HH
authors: Kim
authors: Jong-Hyun
authors: JH
authors: Kim
authors: Kyung-Yil
authors: KY
authors: Lee
authors: Sang Hyuk
authors: SH
authors: Ma
authors: Joon Soo
authors: JS
authors: Park
authors: Hwang Min
authors: HM
authors: Kim
authors: Chun Soo
authors: CS
authors: Kim
authors: Dong Ho
authors: DH
authors: Kim
authors: Young Youn
authors: YY
authors: Choi
authors: Sung-Ho
authors: SH
authors: Cha
authors: Young Jin
authors: YJ
authors: Hong
authors: Jin Han
authors: JH
authors: Kang
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D044466:Asian People; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D015994:Incidence; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: AE, adverse event; CI, confidence interval; FDA, Food and Drug Administration; GMR, geometric mean titer ratio; GMT, geometric mean titer; HI, hemagglutination inhibition; Republic of Korea; USA, United States of America; WHO, World Health Organization; child; clinical trial; influenza; vaccine