摘要
目的评价一款吸附无细胞百日咳(三组分)白喉破伤风联合疫苗(DTcP)应用于2月龄-6岁儿童的安全性。方法采用随机、盲法和同类疫苗对照的Ⅰ期临床试验在河南省某地区招募2月龄、3月龄、18-24月龄和4-6岁受试者,每个年龄组受试者按不同免疫程序随机接种DTcP或对照疫苗,对照疫苗包括已上市使用的吸附无细胞百白破联合疫苗(DTaP)、吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗(DTaP-IPV/Hib)、吸附白喉破伤风联合疫苗(DT),观察接种后0-30 d不良反应和12个月内严重不良事件(SAE),比较DTcP和对照疫苗的不良反应发生率。结果2月龄受试者接种3剂次DTcP(2-3-4月龄免疫程序)、DTaP-IPV/Hib(2-3-4月龄免疫程序)和DTcP(2-4-6月龄免疫程序)的总不良反应发生率分别为21.37%(25/117)、25.42%(30/118)和18.33%(22/120),其中局部反应分别为13.68%、16.10%和12.50%,全身反应分别为11.97%、11.02%和7.50%。3月龄受试者按3-4-5月龄程序接种3剂次DTcP、DTaP和DTaP-IPV/Hib的总不良反应发生率分别为11.67%(14/120)、20.00%(24/120)和32.50%(39/120),其中局部反应分别为7.50%、14.17%和19.17%,全身反应分别为5.00%、7.50%和15.83%。18-24月龄受试者接种1剂次DTcP和DTaP的总不良反应发生率分别为22.50%(9/40)和20.00%(8/40),其中局部反应分别为17.50%和15.00%,全身反应分别为7.50%和5.00%。4-6岁受试者接种1剂次DTcP和DT的总不良反应发生率分别为67.50%(27/40)和17.50%(7/40),其中局部反应分别为67.50%和17.50%,全身反应分别为5.00%和0.00%。所有不良反应的严重程度为1级和2级。9例受试者发生14例次SAE,均与疫苗接种无关。结论本研究初步显示DTcP在2月龄-6岁儿童中接种后具有良好的安全性和耐受性。
Objective To evaluate the safety of a diphtheria,tetanus,and acellular pertussis(three components)adsorbed combined vaccine(DTcP)in children aged 2 months to 6 years.Methods We recruited healthy subjects aged 2 months,3 months,18-24 months,and 4-6 years into a randomized,blinded,controlled phaseⅠclinical trial in a district of Henan province.Subjects in each age group were randomized to receive either DTcP or marketed control vaccines in different vaccination schedules.The control vaccines included diphtheria,tetanus,and acellular pertussis adsorbed combined vaccine(DTaP);diphtheria,tetanus,acellular pertussis,inactivated poliovirus,and Haemophilus influenzae type b(conjugate)adsorbed combined vaccine(DTaP-IPV/Hib);and diphtheria and tetanus adsorbed combined vaccine(DT).We observed for adverse reactions within 30 days and serious adverse events(SAE)within 12 months after vaccination to compare incidences between DTcP and control vaccines.Results Overall incidences of adverse reaction after 3 doses of DTcP(2-3-4-month schedule),DTaP-IPV/Hib(2-3-4-month schedule),and DTcP(2-4-6-month schedule)vaccination in 2-month-olds were 21.37%(25/117),25.42%(30/118),and 18.33%(22/120),respectively,with 13.68%,16.10%,and 12.50%for local reactions and 11.97%,11.02%,and 7.50%for systemic reactions.Overall incidences of adverse reactions after 3 doses of DTcP,DTaP,and DTaP-IPV/Hib vaccination in 3-4-5-month schedule in 3-month-olds were 11.67%(14/120),20.00%(24/120),and 32.50%(39/120),with 7.50%,14.17%,and 19.17%for local reactions and 5.00%,7.50%,and 15.83%for systemic reactions.Overall incidences of adverse reactions after one dose of DTcP and DTaP vaccination in 18-24-month-olds were 22.50%(9/40)and 20.00%(8/40),with 17.50%and 15.00%for local reactions and 7.50%and 5.00%for systemic reactions.Overall incidences of adverse reactions after one dose of DTcP and DT vaccination in 4-6-year-olds were 67.50%(27/40)and 17.50%(7/40),with 67.50%and 17.50%for local reactions and 5.00%and 0.00%for systemic reactions.All adverse reaction
作者
张伟
万鹏
黄丽莉
苟锦博
冯光伟
王雪
谭洁冰
杨永利
王飞雨
黄海涛
王彦霞
Zhang Wei;Wan Peng;Huang Lili;Gou Jinbo;Feng Guangwei;Wang Xue;Tan Jiebing;Yang Yongli;Wang Feiyu;Huang Haitao;Wang Yanxia(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)
出处
《中国疫苗和免疫》
CSCD
北大核心
2023年第6期635-643,共9页
Chinese Journal of Vaccines and Immunization
基金
疫苗临床评价技术平台建设(2018ZX09734004)。
