Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY 13210, USA.
Pediatr Infect Dis J. 2012 Jun;31(6):605-15. doi: 10.1097/INF.0b013e31824e2924.
Children are at high risk of acquiring and transmitting influenza infection and are a high priority group for influenza vaccination.
This was a randomized, observer-blind, multicenter study (NCT00980005) based in the United States. Children were randomized (1:1) to receive either the study vaccine, a thimerosal-free trivalent inactivated influenza vaccine or an active comparator (control vaccine) and were allotted to 1 of 3 age categories: 3-4, 5-8 and 9-17 years. The primary objective was to show noninferiority of the study vaccine versus a US- licensed control influenza vaccine.
A total of 2116 children were vaccinated (study vaccine N = 1055, control vaccine N = 1061). The predefined noninferiority criteria and the Center for Biologics Evaluation and Research criteria for clinical benefit were met for all 3 seasonal virus strains in all children and each age strata. The ratios of the adjusted geometric mean titers (control vaccine over study vaccine) ranged from 0.93 to 1.03 for the 3 virus strains whereas the differences in seroconversion rate (control vaccine minus study vaccine) were between -2.42% and -1.60%. Postvaccination geometric mean titers (range: 213.7-414.7 versus 200.2-451.9) and seroconversion rates (range: 59.8-81.1% versus 58.2-78.6%) were comparable for the 2 vaccines. The safety and reactogenicity profiles were similar for both treatment groups in all age strata.
Immunologic noninferiority of the study vaccine was demonstrated compared with the control vaccine. Furthermore, the study vaccine had a similar safety profile as the control vaccine in children.
儿童感染和传播流感的风险较高，是流感疫苗接种的重点人群。
这是一项在美国进行的随机、观察者盲法、多中心研究（NCT00980005）。儿童以 1:1 的比例随机（随机）接受研究疫苗、无硫柳汞的三价灭活流感疫苗或活性对照物（对照疫苗），并分为 3 个年龄组：3-4 岁、5-8 岁和 9-17 岁。主要目的是证明研究疫苗与美国许可的对照流感疫苗相比具有非劣效性。
共有 2116 名儿童接种了疫苗（研究疫苗 N=1055，对照疫苗 N=1061）。所有儿童和每个年龄组的所有 3 种季节性病毒株均符合预先设定的非劣效性标准和生物制品评估与研究中心的临床获益标准。3 种病毒株的调整几何平均滴度比值（对照疫苗与研究疫苗）范围为 0.93-1.03，而血清转化率差异（对照疫苗与研究疫苗）在-2.42%至-1.60%之间。接种后几何平均滴度（范围：213.7-414.7 与 200.2-451.9）和血清转化率（范围：59.8-81.1%与 58.2-78.6%）在两种疫苗之间相似。在所有年龄组中，两组的安全性和不良反应谱相似。
与对照疫苗相比，研究疫苗具有免疫非劣效性。此外，研究疫苗在儿童中的安全性与对照疫苗相似。
