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目的观察国产流行性感冒(流感)裂解疫苗的安全性和免疫效果。方法以上海生物制品研究所生产的流感裂解疫苗作为试验组,葛兰素史克公司的流感裂解疫苗作为对照组,在上海市虹口区分别接种100名成人进行观察。结果试验组接种后局部反应和全身反应发生率与对照组相似,但局部反应中的红肿和硬结发生人次和反应强度明显低于对照组,但二者的疼痛发生率均>40%。试验组的免疫应答水平基本达到欧盟的标准,流行病学效果与对照组差异无显著的统计学意义。结论试验组的免疫效果与对照组相似,局部反应更温和。
Objective To observe the safety and immune effect of domestic influenza (influenza) split vaccine. Methods Influenza lytic vaccine produced by Shanghai Institute of Biological Products was used as the experimental group and GSK’s flu lytic vaccine was used as the control group. 100 adults were inoculated respectively in Hongkou District, Shanghai. Results The incidence of local reactions and systemic reactions in the experimental group after inoculation were similar to those in the control group. However, the number of local reactions and the reaction intensity of inflamed and indurated lesions in the experimental group were significantly lower than those in the control group, but the incidence of both were> 40%. The level of immune response in the experimental group basically reached the EU standard, and the difference between the epidemiological effect and the control group was not statistically significant. Conclusion The immune effect of the experimental group is similar to that of the control group, and the local reaction is more mild.