摘要
目的比较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／／PRP～T联合疫苗）与吸附无细胞百白破联合疫苗（DTaP）、b型流感嗜血杆菌结合疫苗（Hib结合疫苗）、注射用灭活脊髓灰质炎疫苗（IPV）的免疫原性和安全性。方法受试者随机分为三组。试验组（A组和B组）分别于2、3、4月龄和3、4、5月龄接种DTaP—IPV／／PRP～T联合疫苗，对照组（C组）于3、4、5月龄分别同时接种DTaP、Hib结合疫苗和IPV；3个组均在18～20月龄时加强接种一次。检测每种抗原的抗体滴度，并分别对A、B组与C组的血清保护率／血清转换率进行非劣效性检验。记录每次接种后的安全性数据，并评价疫苗的安全性。结果DTaP．IPV／／PRP～T联合疫苗采用2、3、4月龄或者3、4、5月龄接种程序相对于DTaP、Hib结合疫苗和IPV在基础免疫及18～20月龄的加强免疫，对每种抗原的血清保护率／血清转换率均为非劣效；接种DTaP—IPV／／PRP～T联合疫苗后安全性良好，并与对照疫苗相似。结论DTaP—IPV／／PRP～T联合疫苗对中国婴幼儿具有很高的免疫原性和良好的安全性，并与对照疫苗具有可比性。
Objective The aim of this study was to demonstrate the immunogenicity and safety of diphtheria, tetanus, pertussis （acellular, component） , poliomyelitis （inactivated） vaccine （adsorbed） and Haemophilus influenzae type b conjugate vaccine （DTaP-IPW/PRP-T） combined vaccine compared with commercially available DTaP （diphtheria, tetanus and pertussis）, Haemophilus influenzae type b （Hib） , tetanus conjugate and IPV monovalent vaccine. Methods Subjects were randomly divided into three groups, Group A and Group B were DTaP-IPV//PRP-T combined vaccine （PENTAXIMTM） vaccinated at 2,3,4 months of age or 3,4,5 months of age respectively; Group C was commercially available DTaP. Hib tetanus conjugate （Act-HIBTM） and IPV （IMOVAX PolioTM） vaccines vaccinated at 3,4,5 months of age. All groups received booster dose at 18 to 20 months of age, with antibody titers tested. Non-inferiority analysis was demonstrated in terms of seroprotection / seroconversion rates between Group A, Group B respectively and Group C. Safety information was collected after each vaccination to assess the safety of investigational vaccines. Results The non-inferiority of DTaP-IPV//PRP-T combined vaccine vaccinated at 2,3,4 or 3,4, 5 months of age versus DTaP, Hib tetanus conjugate and IPV vaccine was demonstrated for all vaccine antigens in both primary and booster phases in terms of seroprotection/seroconversion rates. DTaP-IPV//PRP-T combined vaccine was well tolerated. The rate of solicited/unsoliciated severe adverse reactions was very low and similar to the control vaccines. Conclusion DTaP-IPV//PRP-T combined vaccine was highly immunogenic with good safety profile in Chinese infants, which was comparable to the commercially available control vaccines.
出处
《中华流行病学杂志》
CAS
CSCD
北大核心
2011年第8期808-815,共8页
Chinese Journal of Epidemiology
