中国婴幼儿接种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)联合疫苗的安全性和免疫原性研究
중국영유인접충흡부무세포백백파멸활척수회질염화b형류감기혈간균(결합)연합역묘적안전성화면역원성연구
Immunogenicity and safety of DTaP-IPV//PRP-T combined vaccine in infants in China
  • 万方数据
    中华流行病学杂志 중화류행병학잡지
    CHINESE JOURNAL OF EPIDEMIOLOGY
    2011年 8期 808-815 ,共8页

    李艳萍%李凤祥%侯启明%李长贵%李亚南%陈福生%胡学忠%苏文斌%张庶民%方捍华%叶强%曾天德%刘陶宣%李秀必%黄运能%邓曼玲%李荣成%张燕平%Esteban Ortiz

    리염평%리봉상%후계명%리장귀%리아남%진복생%호학충%소문빈%장서민%방한화%협강%증천덕%류도선%리수필%황운능%산만령%리영성%장연평%Esteban Ortiz

    联合疫苗%免疫原性%安全性%基础免疫%加强免疫 聯閤疫苗%免疫原性%安全性%基礎免疫%加彊免疫
    연합역묘%면역원성%안전성%기출면역%가강면역
    Combined vaccine%Immunogenicity%Safety%Primary%Booster
    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.
    목적 비교흡부무세포백백파멸활척수회질염화b형류감기혈간균(결합)연합역묘(DTaP-IPV//PRP～T연합역묘)여흡부무세포백백파연합역묘(DTaP)、b형류감기혈간균결합역묘(Hib결합역묘)、주사용멸활척수회질염역묘(IPV)적면역원성화안전성.방법 수시자수궤분위삼조.시험조(A조화B조)분별우2、3、4월령화3、4、5월령접충DTaP-IPV//PRP～T연합역묘,대조조(C조)우3、4、5월령분별동시접충DTaP、Hib결합역묘화IPV;3개조균재18～20월령시가강접충일차.검측매충항원적항체적도,병분별대A、B조여C조적혈청보호솔/혈청전환솔진행비렬효성검험.기록매차접충후적안전성수거,병평개역묘적안전성.결과 DTaP-IPV//PRP～T연합역묘채용2、3、4월령혹자3、4、5월령접충정서상대우DTaP、Hib결합역묘화IPV재기출면역급18～20월령적가강면역,대매충항원적혈청보호솔/혈청전환솔균위비렬효;접충DTaP-IPV//PRP～T연합역묘후안전성량호,병여대조역묘상사.결론 DTaP-IPV//PRP～T연합역묘대중국영유인구유흔고적면역원성화량호적안전성,병여대조역묘구유가비성.
    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-IPV//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.
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