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目的了解冻干A+C群脑膜炎球菌结合疫苗接种后不良反应发生情况,评价其安全性。方法采用统一的疫苗接种日记卡,由经过培训的专业人员完成,分别调查疫苗第一剂次接种后30min内、第0d(接种当天)、第1d、第2d、第3d、第4d到一月内和第二剂次接种后30min内、第0d(接种当天)、第1d、第2d、第3d、第4d到一周内发热反应以及其他不良反应的发生情况。结果共接种并观察了15 000名适龄儿童,第一剂次共观察到接种不良反应1 222例,不良反应发生率为81.47‰,严重不良反应发生率为1.13‰;第二剂次共观察到不良反应1 110例,不良反应发生率为74.00‰,严重不良反应发生率为0.47‰。除发热外,两剂次均无其他严重不良反应发生。结论冻干A+C群脑膜炎球菌结合疫苗反应轻微,安全性良好。
Objective To understand the incidence of adverse reactions after freeze-dried A + C meningococcal conjugate vaccination and evaluate its safety. Methods A unified vaccination diary card was used by trained professionals to investigate whether the first dose of the vaccine was administered within 30 minutes after inoculation on the first dose, on the 0th day of inoculation, on the 1st, 2nd, 3rd, 4th, Within 30min after inoculation and within the second dose inoculation, on the 0d (the inoculation day), 1d, 2d, 3d, 4d to one week and the occurrence of other adverse reactions. Results A total of 15 000 children of school-age were inoculated and observed. In the first dose, 1,222 adverse reactions were observed. The incidence of adverse reactions was 81.47 ‰ and the incidence of serious adverse reactions was 1.13 ‰. The second dose was observed 110 cases of adverse reactions, the incidence of adverse reactions was 74.00 ‰, the incidence of serious adverse reactions was 0.47 ‰. In addition to fever, no other serious adverse reactions occurred two doses. Conclusions The lyophilized A + C meningococcal conjugate vaccine has mild reaction and good safety.