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[目的]评价国产ACYW135流脑多糖疫苗用于儿童免疫的安全性。[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,调查疫苗接种后30min、6h、12h、24h、48h、72h和接种后7d、15d、1个月不良反应发生情况。[结果]共接种并观察了15317名适龄儿童,发生疫苗接种不良反应1212人,不良反应发生率7.91%。接种后30min、6h、12h、24h、48h、72h的发生率分别为0.36%、0.42%、1.44%、5.15%、0.35%、0.18%,未观察到疫苗接种7d后不良反应。发热反应发生率3.85%,局部反应发生率1.60%,未观察到严重不良反应。[结论]该国产ACYW135流脑多糖疫苗接种反应轻微,安全性好,可以在适龄儿童中进行推广接种。
[Objective] To evaluate the safety of domestic ACYW135 meningitis polysaccharide vaccine for childhood immunization. [Method] A unified vaccination diary card was used by trained professionals to investigate the adverse reactions at 30, 6, 12, 24h, 48h, 72h and 7d, 15d and 1 month after vaccination. [Results] A total of 15317 school-age children were vaccinated and observed. There were 1212 adverse reactions of vaccination. The incidence of adverse reactions was 7.91%. The incidence rates at 30min, 6h, 12h, 24h, 48h and 72h after inoculation were 0.36%, 0.42%, 1.44%, 5.15%, 0.35% and 0.18% respectively. No adverse reactions were observed after 7 days of vaccination. The incidence of fever was 3.85% and the incidence of local reactions was 1.60%. No serious adverse reactions were observed. [Conclusion] The domestic ACYW135 meningitis cerebrospinal fluid vaccine has mild reaction and good safety, and can be popularized in children of school age.