论文部分内容阅读
目的以比利时葛兰素史克(GlaxoSmithKline,GSK)生物制品公司生产的威可檬(Varilrix)冻干水痘减毒活疫苗(Varicella Attenuated Live Vaccine,Freeze-dried;VarV-Fd)作为对照,评价上海(Shanghai,SH)生物制品研究所有限责任公司生产的VarV-Fd的免疫原性和安全性。方法采用随机、双盲、对照方法,对广东省和四川省的467名1~3岁儿童进行了临床观察,比较接种两种VarV-Fd后的抗体(模抗原免疫荧光抗体法,Fluorescent Antibody to Membrane Antigen,FAMA)阳转率和免疫成功率,抗体几何平均滴度(Geometric Mean Titer,GMT)和不良反应发生率。结果接种SH VarV-Fd和GSK VarV-Fd后,抗体阳转率和免疫成功率分别为81.04%和81.59%,GMT分别为1∶8.829和1∶9.671,不良反应发生率分别为10.17%和7.36%。抗体阳转率和免疫成功率(χ2=0.020,P=0.886)、GMT(t=0.786,P=0.432)、不良反应发生率(χ2=1.151,P=0.283)的差异均无统计学意义。结论 SH VarV-Fd与GSK VarV-Fd均具有良好的免疫原性和安全性。
Objective To evaluate the efficacy and safety of Varicella Attenuated Live Vaccine (Varzelauten Live Vaccine, Freeze-dried; VarV-Fd) produced by GlaxoSmithKline (GSK) Shanghai, SH) Immunogenicity and safety of VarV-Fd produced by Institute of Biopharm. Methods A total of 467 children aged 1-3 years old from Guangdong Province and Sichuan Province were enrolled in the study. Randomized, double-blind and control methods were used to compare the results of two antibodies against VarV-Fd (Fluorescent Antibody to Fluorescent Antibody to Membrane Antigen, FAMA positive rate and immune success rate, Geometric Mean Titer (GMT) and the incidence of adverse reactions. Results The positive rates of immunization and immunization of SH VarV-Fd and GSK VarV-Fd were 81.04% and 81.59%, respectively, with the GMTs of 1: 8.829 and 1: 9.671, respectively. The incidences of adverse reactions were 10.17% and 7.36 %. There was no significant difference in antibody positive rate and immune success rate (χ2 = 0.020, P = 0.886), GMT (t = 0.786, P = 0.432) and incidence of adverse reactions (χ2 = 1.151, P = 0.283) Conclusion Both SH VarV-Fd and GSK VarV-Fd have good immunogenicity and safety.