国产流行性感冒裂解疫苗的安全性和免疫效果研究

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。

Research on Safety and Immumo-efficiency of the Domestic Split Flu Vaccine

Objective To observe the safety and immuno-efficiency of domestic split Flu vaccine.Methods Split Flu vaccines of two brands were vaccinated to each 100 adults at Hongkou District of shanghai.One vaccine was vaccinated as the test which was made by Shanghai Institute of Biological Products(domestic),and the other was the control made by GSK.Results Both vaccines have similar incidences of the local and the whole body reaction,but the test has a much lower incidence and less violence of local swell and callosity than the control.They all have much higher rates of local pain with more than 40%.The immuno-reaction of the test generally meats the standard of the Europe Union,and the epidemiology effort is similar to the control.Conclusion The test vaccine has the similar immumo-efficiency compared with the control,but is much tender in reactions.