同时接种肺炎球菌结合疫苗时，白喉、破伤风、5 组分无细胞百日咳、灭活脊髓灰质炎、b 型流感嗜血杆菌结合疫苗的免疫原性和安全性：一项随机、开放标签、3 期研究。
Immunogenicity and safety of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus type b conjugate vaccine when administered concurrently with a pneumococcal conjugate vaccine: a randomized, open-label, phase 3 study.
机构信息
Department of Pediatrics, Dartmouth Medical School, Children's Hospital at Dartmouth, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756, USA.
出版信息
Vaccine. 2011 Mar 3;29(11):2212-21. doi: 10.1016/j.vaccine.2010.06.037. Epub 2010 Jul 6.
A phase 3 randomized, multicenter study evaluated the safety and immunogenicity of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b conjugate vaccine (DTaP(5)-IPV/Hib) administered at the same visit with 7-valent pneumococcal conjugate vaccine (PCV7, concurrent group) or at separate visits (separated by ≥ 15 days; staggered group). DTaP(5)-IPV/Hib was administered at 2, 4, 6, and 15 months of age, and PCV7 was administered concurrently or at 3, 5, 7, and 16 months of age. The study results found that DTaP(5)-IPV/Hib is safe and immunogenic when given concurrently with 7-valent pneumococcal conjugate vaccine.
一项 3 期随机、多中心研究评估了在同一时间接种白喉、破伤风、5 种无细胞百日咳、灭活脊髓灰质炎、b 型流感嗜血杆菌结合疫苗（DTaP[5]-IPV/Hib）与 7 价肺炎球菌结合疫苗（PCV7，同时组）或不同时间接种（间隔≥15 天；交错组）的安全性和免疫原性。DTaP[5]-IPV/Hib 分别在 2、4、6 和 15 个月龄时接种，PCV7 则在 3、5、7 和 16 个月龄时接种。研究结果表明，DTaP[5]-IPV/Hib 与 7 价肺炎球菌结合疫苗同时接种是安全且具有免疫原性的。
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