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目的观察婴儿同时接种b型流感嗜血杆菌-破伤风类毒素(Hib-TT)结合疫苗与国产DTPw疫苗后的反应。方法按照开放、随机的原则,将472名11～17周龄的健康男女婴儿分为2组,即DTPw组(234名)和DTPw+Hib组(238名)。DTPw组接种0.5mlDTPw疫苗,DTPw+Hib组同时在不同部位接种0.5mlHib结合疫苗,2组分别于3、4、5月龄各接种1针。在免疫接种后4d内,观察2组接种对象所有症状(征集与非征集的)的发生情况,对接种当日和随后30d报告的非征集性不良反应进行记录,并进行统计学分析。结果在接种疫苗后4d内,DTPw+Hib组与DTPw组所有症状的发生率相似,分别为49.1%和46.0%;在31d内,2组中出现非征集症状的比例分别为9.9%和9.8%,其中上呼吸道感染和咽喉炎是最常见的非征集性症状;未报告严重不良反应。结论婴儿同时接种DTPw疫苗和Hib结合疫苗具有良好的安全性和耐受性。
Objective To observe the response of infants with Hib-TT combined vaccine and domestic DTPw vaccine. Methods According to the principle of openness and randomness, 472 healthy male and female infants aged 11-17 weeks were divided into two groups: DTPw group (234) and DTPw + Hib group (238). DTPw group inoculated 0.5mlDTPw vaccine, DTPw + Hib group also inoculated 0.5mlHib in different parts of the vaccine, two groups were at the age of 3, 4, 5 months were vaccinated 1 needle. Within 4 days after immunization, the incidence of all symptoms (both solicited and non-solicited) in the two vaccinated groups was observed. The non-solicited adverse reactions reported on the day of vaccination and the subsequent 30 days were recorded and statistically analyzed. Results The incidence rates of all symptoms in DTPw + Hib group and DTPw group were 49.1% and 46.0%, respectively, within 4 days after vaccination. In 31 days, the rates of non-collection of symptoms in both groups were 9.9% and 9.8% Among them, upper respiratory tract infection and pharyngitis were the most common non-solitary symptoms; no serious adverse reactions were reported. Conclusions Infants with both DTPw vaccine and Hib conjugate vaccine have good safety and tolerability.