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[目的]评价某国产流行性感冒裂解疫苗在儿童和成人中应用的安全性及免疫原性,为推广国产流感疫苗的预防接种提供科学依据。[方法]选择6月龄以上健康人群120人作为受试人群,分成6个年龄组,于上臂三角肌肌内接种某公司流行性感冒裂解疫苗,考核和评价疫苗的安全性和免疫原性。[结果]实验疫苗接种首针后全身及局部反应发生率分别为5%及4.17%,该疫苗在18～60岁人群中和≥60岁人群中分型抗体阳转率均≥50%,18～60岁人群和≥60岁人群分型抗体GMT增长﹥4.0倍,18～60岁和≥60岁易感者保护率均≥90%。[结论]本次研究结果与诸多同类疫苗临床反应率大致相同,提示该疫苗具有较好的临床安全性。免疫效果达到欧盟流感疫苗临床试验评价标准。
[Objective] To evaluate the safety and immunogenicity of a domestic-made influenza-lysis vaccine in children and adults and provide a scientific basis for promoting the vaccination of domestic-made influenza vaccines. [Methods] A total of 120 healthy people aged 6 months and over were selected as test subjects and divided into 6 age groups to inoculate intramuscular hypothyroidism with influenza vaccine in a company to evaluate the safety and immunogenicity of the vaccine. [Results] The incidence rates of systemic and local reactions after the first vaccination were 5% and 4.17%, respectively. The positive rate of positive antibody in the population aged 18-60 years and ≥60 years old was ≥50%, 18 The GMTs of typing antibodies in patients aged ~ 60 years and ≥60 years old were> 4.0 times higher than those of susceptible persons aged 18-60 years and ≥60 years. [Conclusion] The results of this study and many similar vaccine clinical response rate is roughly the same, suggesting that the vaccine has good clinical safety. Immune effect reached the EU influenza vaccine clinical trial evaluation criteria.