Khan A S, Polezhaev F, Vasiljeva R, Drinevsky V, Buffington J, Gary H, Sominina A, Keitel W, Regnery H, Lonskaya N L, Doroshenko E, Gavrilov A, Ivakhov I, Arden N, Schonberger L B, Couch R, Kendal A, Cox N
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
J Infect Dis. 1996 Feb;173(2):453-6. doi: 10.1093/infdis/173.2.453.
In a blinded, placebo-controlled study, the reactogenicity, immunogenicity, and clinical efficacy of single doses of US inactivated split-virus and Russian live attenuated, cold-adapted influenza vaccines were compared in 555 schoolchildren in Vologda, Russia. Serial serum samples were collected and school absenteeism was assessed. Systemic reactions were rare, but local reactions (primarily erythema at the injection site) were observed in 27% of the inactivated vaccine group, and coryza (12%) and sore throat (8%) were observed in the attenuated vaccine group. At 4 weeks after vaccination a > or = 4-fold rise in titer of hemagglutination inhibition antibody to A (H1N1), A (H3N2), and B was noted, respectively, among 78%, 88%, and 53% of children who received inactivated vaccine and among 55%, 79%, and 30% of children who received attenuated vaccine. The vaccine efficacy for preventing school absenteeism due to respiratory illness during the period of peak influenza activity was 56% for inactivated vaccine and 47% for attenuated vaccine.
在一项双盲、安慰剂对照研究中，对俄罗斯沃洛格达的555名学童比较了单剂量美国灭活裂解病毒流感疫苗和俄罗斯减毒活冷适应流感疫苗的反应原性、免疫原性及临床疗效。采集了系列血清样本并评估了学校缺勤情况。全身反应罕见，但灭活疫苗组27%的儿童出现局部反应（主要是注射部位红斑），减毒疫苗组观察到有鼻炎（12%）和咽痛（8%）。接种疫苗4周后，接种灭活疫苗的儿童中，分别有78%、88%和53%的儿童对甲型（H1N1）、甲型（H3N2）和乙型流感病毒血凝抑制抗体效价升高≥4倍，接种减毒疫苗的儿童中这一比例分别为55%、79%和30%。在流感活动高峰期，灭活疫苗预防因呼吸道疾病导致学校缺勤的疫苗效力为56%，减毒疫苗为47%。
