【摘要】 目的 对上海生物制品研究所研制生产的流行性感冒病毒裂解疫苗进行临床安全性的研究;方法 试验疫苗为流行性感冒病毒裂解疫苗,上海生物制品研究所生产;对照疫苗为防感灵,法国巴斯德公司生产。接种对象分婴幼儿组、儿童组、成人组和老年组,每组接种试验疫苗至少选择100人,接种对照疫苗不少于 60人。接种后连续 7天测量体温、观察局部反应及其他体征和自觉症状,并记录反应发生和持续时间,按1997年版《预防接种手册》制订的判断标准分类;结果 试验疫苗组接种 576人次,有 11人次在接种疫苗后发生发热反应,总发热率为1.91％;婴幼儿组有1人接种疫苗后发生皮疹,皮疹发生率为0.17％;对照疫苗组接种301人次,有5人在接种疫苗后发生发热反应,总发热率为1.66％;婴幼儿组有1人接种疫苗后全身出现皮疹,皮疹发生率为 0.33％;结论 国产的流行性感冒病毒裂解疫苗具有很好的临床安全性,国产和进口流感疫苗之间发热反应率、皮疹发生率差异无显著的统计学意义。更多还原

【Abstract】 Objective To observe the clinical safety of Split Influenza Virus Vaccine, which were produced by the Shanghai Institute of Biological Products. Methods we take the Split Influenza Virus Vaccine, which were produced by the Shanghai institute of Biological Products, as the trial vaccine and take the Vaxigrip, which were produced by the Pasteur Merieux s.v. as the contrast vaccine. The vaccinated objects were divided into four groups: infants, children, adults and aged. In each group, we selected 100 persons at least to inoculate the trial vaccine and selected more than 60 persons to inoculate contrast one. After inoculated, we measured the body temperature, observed the local response etc signs and symptoms of the vaccinated objects, and recorded the time of the response taken place for 7 days continuously. We classified the responses according to the judgment standard of "handbook for preventive inoculation", which were edited in 1997. Results We inoculated 576 person-times in the group of trial vaccine. There were 11 person-times occurring fever after vaccinated, the total fever rate is 1.91%. There was 1 person occurred tatter in infants’ group after vaccinated, the occurred rate is 0.17%. We inoculated 301 person-times in the group of contrast vaccine. There were 5 person-times occurring fever after vaccinated, the total fever rate is 1.66%. There was 1 person occurred general tatters in infants’ group after vaccinated, the occurred rate is 0.33%. Conclusion The domestic Split Influenza Virus Vaccine has a very good clinicalsafety. There wasn’t any significant difference in the fever rate and the tetter occurred rate between the domestic products of the influenza vaccine and the imported one.更多还原