【摘要】 目的评价国产流行性感冒裂解疫苗的安全性和免疫原性。方法按整群随机抽样原则,以进口同类疫苗作为对照开展现场临床试验;比较两种疫苗免疫后临床反应率、抗体阳转率、保护率及几何平均滴度(GMT)。结果试验组及对照组接种后发热反应率分别为1.4%和2.1%(P>0.05),局部反应率分别为1.6%和1.7%(P>0.05);试验疫苗流感病毒H1N1、H3N2及B(亚)型的HI抗体总阳转率分别为75.30%、75.30%、42.59%;对照疫苗流感病毒H1N1、H3N2及B(亚)型的HI抗体总阳转率分别为75.10%、77.08%、39.52%;三(亚)型流感抗体总阳转率无统计学意义。三(亚)型流感抗体增长倍数均无统计学意义。三(亚)型流感HI抗体达到保护水平的保护率均无统计学意义。结论国产流感裂解疫苗发热反应和局部反应与进口同类疫苗无差异,免疫后抗体阳转率较高,抗体滴度上升幅度较大,具有良好的临床安全性和免疫原性。更多还原

【Abstract】 Objective To evaluate the safety and immunogenicity of split influenza virus vaccine.Methods Samples were chosen by cluster and random method,and divided into split vaccination group and the homo-imported influenza vaccination group.Results After injection,the fever-reaction rates of trial group and control group were 1.4% and 2.1%((P>0.05)),the local reaction rates were(1.6%) and (1.7%)((P>0.05)).After immunization,the antibody positive rates of trail and control groups did not appeared statistically significant(H3N2:(75.30%) vs 75.10%,H1N1:75.30% vs 77.08%, B:(42.59%) vs(39.52%)).For GMT of type H1N1,H3H2 and B antibody,trial group increased averagely(15.8),(5.1) and 5.8 times,control group increased 16.0,5.3 and 5.6times.Conclusions Influenza split vaccine made in Dalian Kunyang company its safety and immunogenicity were good as homo-imported vaccine.更多还原