白喉-破伤风-无细胞百日咳-b型流行性感冒嗜血杆菌联合疫苗对中国婴儿安全性和免疫原性的研究  

Safety and Immunogenicity of the Diphtheria,Tetanus,Accellular Pertussis Plus Hemophilus Influenza Type b Combined Vaccine(DTaP-Hib)to Chinese Infants

作　　者：李艳萍[1] 张庶民[2] 叶强[2] 侯启明[2] 李亚男[2] 李红[2] 徐颖华[2] 马霄[2] 刘幼平[3] 陈晓玲 黄莉荣[1] Gunasekaran Ramakrishnan 李荣成[1] 赵雷 唐海文 Olivier Van Der Meeren Hans L Bock 

机构地区：[1]广西壮族自治区疾病预防控制中心,南宁530028 [2]中国药品生物制品检定所,北京100050 [3]梧州市疾病预防控制中心,广西壮族自治区梧州540000 [4]蒙山县疾病预防控制中心,广西壮族自治区蒙山546700 [5]GlaxoSmithKline Biologicals, Rue de 1'Institut 89 B-1330 Rixensart, Belgium

出　　处：《中国疫苗和免疫》2010年第2期97-104,共8页Chinese Journal of Vaccines and Immunization

基　　金：比利时葛兰素史克公司对本研究提供资金支持

摘　　要：目的评价白喉-破伤风-无细胞百日咳-b型流行性感冒嗜血杆菌联合疫苗(Diphtheria,Tetanus,Acellular Pertussis and Haemophilus Influenzae Type b Combined Vaccine;DTaP-Hib),对中国婴儿的安全性和免疫原性。方法通过一项安全性研究(研究A)和一项安全性及免疫原性研究(研究B),评价DTaP-Hib联合疫苗接种于3、4、5月龄婴儿的安全性及免疫原性,并与DTaP联合疫苗及Hib疫苗(DTaP+Hib)同时分别接种进行比较。结果共690名健康婴儿接受了DTaP-Hib联合疫苗或DTaP联合疫苗与Hib疫苗分别同时接种的基础免疫。DTaP-Hib联合疫苗的耐受性与DTaP联合疫苗+Hib疫苗分别接种一致,两组局部及全身不良反应发生率差异无统计学意义。在接种DTaP-Hib联合疫苗的受试者中,至少有97.5%在基础免疫后一个月产生了针对白喉、破伤风、Hib的血清学保护性抗体,以及对无细胞百日咳抗原的免疫应答。按照预先制订的标准,DTaP-Hib联合疫苗的免疫应答与DTaP联合疫苗+Hib疫苗分别接种免疫应答应的差异无统计学意义。结论DTaP-Hib联合疫苗接种后可获得预期的安全性和免疫原性。临床试验注册国家食品药品监督管理局《药物临床批件》2003L03331。Objective To evaluate the safety and immunogenicity of combined diphtheria,tetanus,accellular pertussis Plus hemophilus influenza type b vaccine（DTaP-Hib）to Chinese infants.Methods Safety study（study A）,and immunogenicity and safety study（study B）were conducted in infants aged 3,4 and 5 months.The immune response and safety of the DTaP-Hib vaccine were compared after administered DTaP and Hib separately based on specified criteria.Results A total of 690 healthy infants received primary vaccination with combined DTaP-Hib or administered DTaP and Hib（DTaP＋Hib）separately.Immunogenicity was assessed before and one month after vaccination in a subjet.The tolerance of DTaP-Hib vaccine was at least as same as administered DTaP＋Hib separately.The differences of local and general adverse events following immunigation（AEFI）between groups had no difference statisticaly significantly.At least 97.5% of DTaP-Hib recipients had seroprotection against diphtheria,tetanus and Hib,and response to acellular pertussis antigens one month after primary vaccination.The immune response of the DTaP-Hib vaccine was comparable to administered DTaP＋Hib based on specified criteria separately.Conclusion The combined DTaP-Hib vaccine gets expected safety and immunogenicity.Clinical Trial Registration State Food and Drug Administration.Approval Number：2003L03331.

关 键 词：白喉-破伤风-无细胞百日咳-b型流行性感冒嗜血杆菌联合疫苗 安全性 免疫原性 

分 类 号：R186[医药卫生—流行病学]