AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗安全性研究  

Study on safety of post marketing group A and C meningococcal conjugate and haemophilus type b conjugate combined vaccine

作　　者：苗伟[1] 卜洁琼[1] 胡顺富[1] MIAO Wei;BU Jie-qiong;HU Shun-fu(Rizhao City Center for Disease Control and Prevention,Rizhao,Shandong,276800,China)

机构地区：[1]日照市疾病预防控制中心,山东日照276800

出　　处：《预防医学论坛》2022年第1期35-37,共3页Preventive Medicine Tribune

基　　金：山东预防医学会智飞疾病预防控制技术研究基金项目计划(项目编号:LYH2017-27)。

摘　　要：目的评价AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗(Men-AC-Hib)在2~71月龄儿童中接种的安全性。方法在日照市2个区县选择2~71月龄健康者接种Men-AC-Hib,采用被动监测方式观察和收集,对各种不良反应发生率进行分析。结果对2017-2020年7450名观察对象累计接种13431剂次后进行安全性观察,共收集到疑似预防接种异常反应7例,经判定均为不良反应中的一般反应。按年龄组分5例为6~11月龄组,2例不良反应为12~71月龄组,2~5月龄组未监测到不良反应;按症状分为发热5例(发生率3.72‰)、发红2例(发生率1.49‰)、接种部位瘙痒1例(发生率0.74‰)、腹泻1例(发生率0.74‰)和一过性皮疹1例(发生率0.74‰)。按严重程度分为1级反应1例,2级反应3例,3级反应3例,无4级反应。未发现与Ⅲ期临床试验的观察结果有差异。接种Men-AC与接种Men-AC-Hib的不良反应发生率差异无统计学意义(P>0.05)。结论日照市2~71月龄儿童接种Men-AC-Hib具有良好的安全性。Objective To evaluate the safety of post marketing group A and C meningococcal conjugate and haemophilus type b conjugate combined vaccine(Men-AC-Hib)among children aged 2-71 months.Methods Healthy subjects aged 2 to 71 months were inoculated with Men-AC-Hib in 2 districts of Rizhao city.The adverse events were observed and collected by passive monitoring method,and the incidence of adverse reactions was analyzed.Results A total of 13431 doses of vaccination were administered to 7450 subjects during 2017-2020 for safety observation.A total of 7 cases of suspected abnormal reactions to vaccination were collected,which were determined to be general reactions among the adverse reactions.According to the symptoms,they were divided into 5 cases of fever(3.72‰),2 cases of redness(1.49‰),1 case of pruritus at the inoculation site(0.74‰),1 case of diarrhea(0.74‰)and 1 case of transient rash(0.74‰).According to the severity,there were 1 case of grade 1 reaction,3 cases of grade 2 reaction,3 cases of grade 3 reaction,and no grade 4 reaction.There was no significant difference in the incidence of ADR between MEN-AC and MEN-AC-Hib respectively(P>0.05).Conclusion Men-AC-Hib is safe for children aged 2-71 months.

关 键 词：疫苗接种 AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗 安全性研究 

分 类 号：R186[医药卫生—流行病学]