【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。更多还原

【Abstract】 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.更多还原