| Autor: |
Yan-ping, Li, Feng-xiang, Li, Qi-ming, Hou, Chang-gui, Li, Ya-nan, Li, Fu-sheng, Chen, Xue-zhong, Hu, Wen-bin, Su, Shu-min, Zhang, Han-hua, Fang, Qiang, Ye, Tian-de, Zeng, Tao-xuan, Liu, Xiu-bi, Li, Yun-neng, Huang, Man-ling, Deng, Rong-cheng, Li, Yan-ping, Zhang, Ortiz, Esteban |
| Rok vydání: |
2011 |
| Předmět: |
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| Zdroj: |
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi. 32(8) |
| ISSN: |
0254-6450 |
| Popis: |
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.Subjects were randomly divided into three groups, Group A and Group B were DTaP-IPV//PRP-T combined vaccine (PENTAXIM(TM)) 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-HIB(TM)) and IPV (IMOVAX PolioTM(TM)) 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.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/unsolicited severe adverse reactions was very low and similar to the control vaccines.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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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