| 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,EstebanOrtiz.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[J].Chinese journal of Epidemiology,2011,32(8):808-815 |
| 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 |
| Immunogenicity and safety of DTaP-IPV//PRP-T combined vaccine in infants in China |
| Received:April 28, 2011 |
| DOI： |
| KeyWord: 联合疫苗 免疫原性 安全性 基础免疫 加强免疫 |
| English Key Word: Combined vaccine Immunogenicity Safety Primary Booster |
| FundProject: |
| Author Name | Affiliation | E-mail | | Li Yan-pingHuang Yun-neng，Deng Man-ling，Li Rong-cheng，Zhang Yan-ping，Esteban Ortiz | Guangxi Autonomous Region Center for Disease Control and Prevention,Nanning 530023,China | | | Li Feng-xiang | Chinese National Institute for Food and Drug Control（NIFDC） | | | Hou Qi-ming | Chinese National Institute for Food and Drug Control（NIFDC） | | | Li Chang-gui | Chinese National Institute for Food and Drug Control（NIFDC） | | | Li Ya-nan | Chinese National Institute for Food and Drug Control（NIFDC） | | | Chen Fu-sheng | Pingle County Center for Disease Control andPrevention,Guangxi | | | Hu Xue-zhong | Lipu County Center for Disease Control and Prevention,Guangxi | | | Su Wen-bin | Yangshuo County Center for Disease Control and Prevention,Guangxi | | | Zhang Shu-min | Chinese National Institute for Food and Drug Control（NIFDC） | | | Fang Han-hua | Chinese National Institute for Food and Drug Control（NIFDC） | | | Ye Qiang | Chinese National Institute for Food and Drug Control（NIFDC） | | | Zeng Tian-de | Pingle County Center for Disease Control andPrevention,Guangxi | | | Liu Tao-xuan | Lipu County Center for Disease Control and Prevention,Guangxi | | | Li Xiu-bi | Yangshuo County Center for Disease Control and Prevention,Guangxi | | | Huang Yun-neng | Guilin City Center for Disease Control
and Prevention,Guangxi | | | Deng Man-ling | Guilin City Center for Disease Control
and Prevention,Guangxi | | | Li Rong-cheng | Guangxi Autonomous Region Center for Disease Control and Prevention,Nanning 530023,China | lrch2001@163.com | | Zhang Yan-ping | Chinese Medical Affairs,Sanofi Pasteur | | | Esteban Ortiz | Global Medical Affairs,Sanofi Pasteur,Lyon,France | |
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| Abstract: |
| 目的<\b>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<\b>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<\b>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<\b>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。 |
| English Abstract: |
| 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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