福氏2a痢疾结合疫苗临床安全性观察  

Studies on safety of Shigella flexneri 2a conjugate vaccine

作　　者：陈昌标[1] 周伟忠[2] 姜仁杰[3] 顾建祥[1] 周锦国[1] 赵志强[4] 

机构地区：[1]射阳县疾病预防控制中心,江苏射阳224300 [2]江苏省疾病预防控制中心,江苏南京210009 [3]盐城市疾病预防控制中心,江苏盐城224002 [4]兰州生物制品研究所,甘肃兰州730000

出　　处：《江苏预防医学》2007年第2期3-5,共3页Jiangsu Journal of Preventive Medicine

摘　　要：目的:评价福氏2a痢疾结合疫苗临床安全性。方法:按随机、对照、盲法的原则,以不含福氏2a痢疾结合物疫苗成份的磷酸缓冲盐水作为安慰剂对照,开展现场临床试验,比较试验疫苗组和对照组免后反应率。结果:接种福氏2a痢疾结合疫苗2针后全身反应平均发生率为1.11%,其中弱反应占62.5%,中反应占37.5%,无强反应发生。局部反应平均发生率为8.89%。各年龄段试验疫苗组全身反应和局部反应发生率和对照组相比无统计学差异。结论:福氏2a痢疾结合疫苗在2岁以上的人群中接种是安全的。Objective： To evaluate the clinical safety of Shigella flexneri 2a conjugate vaccine. Methods： Comparing the immune reaction of experimental group of Shigella flexneri 2a conjugate vaccine with control group of phosphate--buffered saline by random and double blind study. Results： The mean reaction rate of whole-body was 1. 11% after being administered a 2 dose Shigella flexneri 2a conjugate vaccine. Of which, 62. 5% with lower reaction, 37. 5%with medium reaction and without any strong reaction occurred. The mean reaction rate of local body was 8. 89%. There were no statistically significant differences existed on reaction rate both whole and local body between experimental group and control group in different age groups. Conclusion： It was shown that Shigella flexneri 2a conjugate vaccine was safe for over 2 years old group.

关 键 词：痢疾 疫苗 安全性 评估 

分 类 号：R186.3[医药卫生—流行病学]