摘要
目的为了评价3价流行性感冒(流感)裂解疫苗安尔来福TM的安全性和免疫原性。方法于2003年6~11月在广西壮族自治区南宁市和柳城县进行以进口同类疫苗为对照的临床研究。受试者为>6个月~>60岁健康人群1 332人,接种疫苗后对受试者进行不良反应观察,应用微量血凝抑制(HI)试验对受试者血清进行抗体分型检测。结果试验疫苗组与对照疫苗组各有1例出现接种部位红肿,均在72h内消失;试验组与对照组发热反应率分别为3.21%(35/1 092)、6.25%(15/240),差异有显著的统计学意义。未见其它不良反应发生。试验组和对照组各有734人和163人检测了HI抗体,结果各型HI抗体总阳转率分别为50.0%~84.2%和57.7%~84.0%,抗体几何平均滴度分别增长4.2~11.4倍和5.7~11.6倍,差异均无显著的统计学意义。结论试验疫苗的免疫效果达到欧盟标准,表明流感裂解疫苗安尔来福TM的安全性、免疫原性良好,适于推广使用。
Objective To evaluate the safety and immunogenicity of a trivalent split influenza virus vaccine produced by Sinovac Biotech Co., Ltd. Methods Guangxi Zhuang Nationality Municipality Center for Disease The clinical trial was carmed out by Control and Prevention in Nanning City and Liucheng County of Guangxi from June,2003 to September 10,2003. 1332 subjects were screened from the over-6-month variedly-aged healthy persons. After vaccination,adverse events of the subjects were observed and the different types antibodies of the subjects were tested by the micro-hemagglutination inhibition （HI） test. Results One case of Redness and swelling occurred in both test group and control group, respectively. The phenomenas disappeared within 72 hours. The rate of the fever was 3.21% and 6.25 % in the test group and the control group, respectively. The results showed significant statistical difference. Other adverse events were not detected. 734 subjects in the test group and 163 subjects in the control group were tested by HI test. The anti-HI seroconversion rate were 50.0 84.2 % and 57.7～ 84.0 % , respectively. The Anti-HI GMT of three influenza virus（sub-） types increase from 4.2 to 11.4 folds and 5.7 to 11.6 folds for the test group and the control group, respectively, and statistical difference was not significant. Conclusion vaccine-Anflu^TM has excellent safety and immunogenicty and may These results indicated that the trial be suited for wide use.
出处
《中国计划免疫》
2005年第5期343-347,共5页
Chinese Journal of Vaccines and Immunization
作者简介
李艳萍（1957-）,女,湖南省邵阳市人,广西壮族自治区疾病预防控制中心副主任技师,主要从事病毒性疾病防治研究.
