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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。
Objective To study the clinical safety of the influenza virus lytic vaccine developed and produced by Shanghai Institute of Biological Products. Methods The vaccine was tested for influenza virus lytic vaccine and was produced by Shanghai Institute of Biological Products. The control vaccine was anti-allergy. Sid company production. Inoculation groups were divided into infants group, children group, adult group and old group. At least 100 vaccination vaccines were given to each group and no less than 60 vaccinated vaccines. After inoculation, the body temperature was measured for 7 consecutive days to observe the local reactions and other signs and symptoms. The occurrence and duration of the reaction were recorded and classified according to the criteria set forth in the 1997 edition of the Vaccination Manual. Results The vaccine group inoculated was 576 with 11 The incidence of fever was 1.91% after immunization. One infant in the infant group had a rash after vaccination, with a rash of 0.17%. In the control vaccine group, 301 people were vaccinated and 5 were vaccinated Fever reaction, the total fever rate was 1.66%; 1 group of infants and young children after vaccination rash appeared in the body, the incidence of rash was 0.33%; Conclusion domestic influenza virus lysed vaccine has good clinical safety, domestic and imported There was no significant difference in the rate of fever response between influenza vaccines and the incidence of rash.