[Safety and immunogenicity of the diphtheria, tetanus, accellular pertussis plus hemophilus influenza type b combined vaccine (DTaP-Hib) to Chinese infants].

中国疫苗和免疫 Pub Date : 2010-04-01

Yan-ping Li, Shu-min Zhang, Qiang Ye

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Abstract

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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[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]。

目的:评价白喉、破伤风、无细胞百日咳加b型流感嗜血杆菌联合疫苗(DTaP-Hib)对中国婴幼儿的安全性和免疫原性。方法:对3、4、5月龄婴儿进行安全性研究(研究A)和免疫原性及安全性研究(研究B)。根据规定的标准分别接种DTaP和Hib疫苗后，比较了DTaP-Hib疫苗的免疫反应和安全性。结果:共有690名健康婴儿接受了DTaP-Hib联合初次接种或分别接种DTaP和Hib(DTaP+Hib)。免疫原性在接种疫苗前和接种后一个月进行评估。DTaP-Hib疫苗的耐受性至少与单独接种DTaP+Hib疫苗相同。免疫后局部不良事件和一般不良事件(AEFI)组间差异无统计学意义。至少97.5%的DTaP-Hib接种者在初次接种后一个月对白喉、破伤风和Hib有血清保护，对无细胞百日咳抗原有反应。DTaP-Hib疫苗的免疫应答与单独根据特定标准接种的DTaP+Hib疫苗相当。结论:DTaP-Hib联合疫苗具有预期的安全性和免疫原性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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中国疫苗和免疫

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