摘要
目的对市售冻干水痘减毒活疫苗(Varicella Attenuated Live Vaccine,Freeze-dried;VarV-Fd)的安全性及免疫效果进行监测和评价。方法用随机整群抽样法,抽取永兴、永顺县5070名3～9岁儿童,其中2596名儿童接种VarV-Fd(观察组),2474名接种麻疹-流行性腮腺炎联合减毒活疫苗(对照组),观察接种疫苗后28d中不良反应和93名儿童免疫前、后血清抗体水平及两年的流行病学效果。采用统计产品与服务解决方案(Statistical Productand Service Solutions,SPSS)13.0进行统计学分析。结果观察组不良反应总发生率1.62%(42/2596);VarV-Fd保护率为97.82%;免疫前抗体阴性组(<1:4)阳转率为96.4%(27/28),阳性组(≥1:4)抗体≥4倍增长率100%(65/65),差异无统计学意义(Fisher确切概率法,Pi=0.301);但免疫后抗体几何平均滴度阳性组明显高于阴性组,差异有统计学意义(t=43.088,P=0.0000))。结论 VarV-Fd有良好的安全性和免疫效果。
Objective To make surveillance and assessment on safety and immunological effect of varieella attenuated live vaccine （freeze-dried）（VarV-Fd）. Methods Cluster sampling was applied to a number of 5,070 children aged 3-9 in Yongxin and Yongshun county of Hunan province. Among them, 2,596 was immunized with VarV-Fd （observation group）, and the other 2,474 immunized with measles and mumps combined attenuated live vaccine （control group）. Observing adverse reaction in 28 days following innoculation and serum antibiotic level of 93 children before and after vaccination, epidemiological effect in later 2 years was studied as well.＇ Adopt statistical product and service solutions 13.0 to make statistical analysis. Results The general incidence rate of adverse reaction in observation group was 1.62% （42/2596）, VarV-Fd protection rate was 97.82%; the conversion rate for the group with negative antibiotic level before vaccination （ 〈 1：4 ） was 96.4 % （27/28）, and 100 % （65/65） for positive group （≥1：4）, with 4 times or more increase of antibody level, which has no statistical significance （difference Fisher＇s Exact Probability, Pi=0.301 ）. However, the geometric mean titer （GMT）in positive group was obviously higher than negative group, the difference has significance（t=43.088, P=0.0000）. Conclusions VarV-Fd has a good safety and ideal immunological effect.
出处
《中国疫苗和免疫》
CAS
2011年第6期531-534,共4页
Chinese Journal of Vaccines and Immunization
关键词
冻干水痘减毒活疫苗
安全性
免疫效果
Varicella attenuated live vaccine （freeze-dried）
Safety
Immunological effect
