3-23月龄儿童接种A群C群脑膜炎球菌多糖结合疫苗的安全性Ⅲ期临床试验  

Safety of a group A and group C meningococcal polysaccharide conjugate vaccine among 3-23-month-old children:a phaseⅢclinical trial

作　　者：王彦霞[1] 王雪 黄海涛 谢志强[1] 黄丽莉[1] 苟锦博 周翰驰 杨永利[3] 张伟[1] 由汪洋 谭洁冰 冯光伟 许丽锋 朱涛 郭万申[1] Wang Yanxia;Wang Xue;Huang Haitao;Xie Zhiqiang;Huang Lili;Gou Jinbo;Zhou Hanchi;Yang Yongli;Zhang Wei;You Wangyang;Tan Jiebing;Feng Guangwei;Xu Lifeng;Zhu Tao;Guo Wanshen(Henan Provincial Center for Disease Control and Prevention,Zhengzhou 450016,Henan,China;CanSino Biologics Inc,Tianjin 300462,China;Department of Epidemiology and Biostatistics,College of Public Health,Zhengzhou University,Zhengzhou 450001,Henan,China)

机构地区：[1]河南省疾病预防控制中心,河南郑州450016 [2]康希诺生物股份公司,天津300462 [3]郑州大学公共卫生学院计算机与卫生统计学教研室,河南郑州450001

出　　处：《中国疫苗和免疫》2022年第4期440-445,共6页Chinese Journal of Vaccines and Immunization

基　　金：疫苗临床评价技术平台建设(2018ZX09734004)。

摘　　要：目的评价一种A群C群脑膜炎球菌多糖结合疫苗(Group A and group C meningococcal polysaccharide conjugate vaccine,MPCV-AC)应用于3-23月龄儿童的安全性。方法采用随机、盲法、同类疫苗对照的非劣效临床试验,在河南省某县招募3月龄、6-11月龄和12-23月龄健康受试者,每个年龄组受试者按不同免疫程序随机接种MPCV-AC试验疫苗或对照疫苗,观察接种后0-30d不良反应,比较试验疫苗和对照疫苗的不良反应发生率。结果3月龄受试者接种试验疫苗和对照疫苗的总不良反应发生率分别为18.9%(151/799)和29.2%(235/805)(χ^(2)=23.25,P<0.001),其中局部反应分别为1.9%和7.1%(χ^(2)=25.32,P<0.001),全身反应分别为17.3%和24.8%(χ^(2)=13.83,P<0.001)。6-11月龄受试者接种试验疫苗和对照疫苗的总不良反应发生率分别为22.4%(122/545)和21.6%(118/547)(χ^(2)=0.11,P=0.746),其中局部反应分别为2.0%和1.8%(χ^(2)=0.05,P=0.819),全身反应分别为20.7%和20.1%(χ^(2)=0.07,P=0.798)。12-23月龄受试者接种试验疫苗和对照疫苗的总不良反应发生率分别为15.1%(83/548)和19.0%(103/542)(χ^(2)=2.87,P=0.091),其中局部反应分别为0.9%和1.3%(χ^(2)=0.36,P=0.549),全身反应分别为14.2%和18.3%(χ^(2)=3.26,P=0.071)。结论本研究MPCV-AC试验疫苗应用于3-23月龄健康儿童的安全性非劣于对照疫苗。Objective To evaluate the safety of a group A and C meningococcal polysaccharide conjugate vaccine(MPCV-AC)among 3-23-month-old children.Methods We conducted a randomized,blinded,similar-vaccine controlled,non-inferiority clinical trial among healthy subjects aged 3 months,6-11 months,and 12-23 months in a county of Henan province.Subjects in each age group were randomly assigned to receive either the test or control MPCV-AC vaccine in their immunization schedules.We observed for adverse reactions occurring within 30 days after vaccination and compared incidences of adverse reactions between the test and control vaccines.Results Among 3-month-old subjects,overall incidences of adverse reactions for the test and control vaccines were 18.9%(151/799)and 29.2%(235/805)(χ^(2)=23.25,P<0.001),respectively,with 1.9%and 7.1%incidences of local reactions(χ^(2)=25.32,P<0.001)and 17.3%and 24.8%incidences of systemic reactions(χ^(2)=13.83,P<0.001).Among 6-11-month-old subjects,overall incidences of adverse reactions for the test and control vaccines were 22.4%(122/545)and 21.6%(118/547)(χ^(2)=0.11,P=0.746),respectively,2.0%and 1.8%for local reactions(χ^(2)=0.05,P=0.819)and 20.7%and 20.1%for systemic reactions(χ^(2)=0.07,P=0.798).Among 12-23-month-old subjects,overall incidences of adverse reactions for the test and control vaccines were 15.1%(83/548)and 19.0%(103/542)(χ^(2)=2.87,P=0.091),respectively,0.9%and 1.3%for local reactions(χ^(2)=0.36,P=0.549)and 14.2%and 18.3%for systemic reactions(χ^(2)=3.26,P=0.071).Conclusions The safety of the test MPCV-AC vaccine among 3-23-month-old children was non-inferior to the control vaccine.

关 键 词：A群C群脑膜炎球菌多糖结合疫苗 不良反应 安全性 临床试验 非劣效 

分 类 号：R186.3[医药卫生—流行病学]