{"title":"[白喉、破伤风、无细胞百日咳加b型流感嗜血杆菌联合疫苗对中国婴儿的安全性和免疫原性]。","authors":"Yan-ping Li, Shu-min Zhang, Qiang Ye","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the safety and immunogenicity of combined diphtheria, tetanus, accellular pertussis Plus hemophilus influenza type b vaccine (DTaP-Hib)to Chinese infants.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The combined DTaP-Hib vaccine gets expected safety and immunogenicity.</p>","PeriodicalId":56402,"journal":{"name":"中国疫苗和免疫","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2010-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Safety and immunogenicity of the diphtheria, tetanus, accellular pertussis plus hemophilus influenza type b combined vaccine (DTaP-Hib) to Chinese infants].\",\"authors\":\"Yan-ping Li, Shu-min Zhang, Qiang Ye\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the safety and immunogenicity of combined diphtheria, tetanus, accellular pertussis Plus hemophilus influenza type b vaccine (DTaP-Hib)to Chinese infants.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The combined DTaP-Hib vaccine gets expected safety and immunogenicity.</p>\",\"PeriodicalId\":56402,\"journal\":{\"name\":\"中国疫苗和免疫\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2010-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中国疫苗和免疫\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国疫苗和免疫","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
[Safety and immunogenicity of the diphtheria, tetanus, accellular pertussis plus hemophilus influenza type b combined vaccine (DTaP-Hib) to Chinese infants].
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.
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