摘要
目的分析国产肠道病毒71型(EV71)灭活疫苗上市后在大人群(IV期临床试验)接种中的安全性,为国产EV71灭活疫苗的广泛接种提供参考。方法按自愿自费知情同意原则,在北京市朝阳区选取2016年8月—2017年12月按程序接种国产EV71疫苗的25 995名6～71月龄常住健康婴幼儿作为观察对象,于受种婴幼儿上臂三角肌肌内注射,共免疫2剂次,观察受种婴幼儿每剂接种后30 min的即时反应,并通过接种医生电话访视或法定监护人收集受种婴幼儿每剂接种后30 d内的全身、局部和其他不良事件记录在《不良事件主动监测登记表》上,参照国家食品药品监督管理局关于《预防用疫苗临床试验不良事件分级标准指导原则》对注射部位红肿、注射部位硬结、发热进行分级,同时统计不良事件发生率。结果观察的25 995名婴幼儿共计接种国产EV71疫苗52 260剂次,接种共发生总不良事件1 730例次,发生率为3.31%。其中,全身、局部和其他不良事件分别为1 178、516和36例次,发生率分别为2.25%、0.99%和0.07%;在注射部位红肿、注射部位硬结、发热等不良事件中,1、2和3级不良事件分别为362、537和36例次,发生率分别为0.69%、1.03%和0.07%,未见≥4级及罕见和极罕见不良事件,所有不良事件均经药物或门诊治疗痊愈。结论国产EV71疫苗具有较好的安全性。
Objective To evaluate the safety of a homemade inactivated enterovirus type 71 (EV71) vaccine in a phase IV clinical trial in a large population of children and to provide references for extensive inoculation of the vaccine. Methods Totally 25 995 healthy children aged 6-71 months were vaccinated with a self-paid inactivated EV71 vaccine under their parents′ informed consent between August 2016 and December 2017 in Chaoyang district of Beijing city. The two doses of the vaccination were administered with intramuscular injection at upper arm deltoid. Immediate adverse reactions within 30 minutes of the vaccination were observed;general and local reactions and other adverse events within 30 days after the inoculation were recorded via follow-up telephone interview and the reporting of the children's statutory guardians. We graded the observed adverse events (local red/swollen and induration and fever) following the vaccination with references to the Guidelines for Classification of Adverse Events for Preventive Vaccine Clinical Trials issued by National Food and Drug Administration. We also calculated the incidence rate of the adverse events simultaneously. Results Totally 1 730 adverse events occurred following vaccinations of 52 260 doses of homemade inactivated EV71 vaccine among all the children inoculated, with an incidence rate of 3.31%. Of all the abnormal reactions observed, 1 178, 516, and 36 were general, local, and other adverse events, with the incidence rate of 2.25%, 0.99%, and 0.07%, respectively. Among all the adverse events reported, 362, 537, and 36 were classified as grade I, II, and III adverse events, with the incidence rate of 0.69%, 1.03%, and 0.07%. No grade IV or higher, rare, and extremely rare adverse events were reported. All the reported adverse events were cured with medication or outpatient treatment. Conclusion The homemade EV71 vaccine is of good safety when inoculated in a large population of children.
作者
张文静
时念民
张彦利
张馨月
和彦苓
白云骅
ZHANG Wen-jing;SHI Nian-min;ZHANG Yan-li(School of Public Health,Baotou Medical College,Baotou,Inner Mongolia Autonomous Region 014040,China)
出处
《中国公共卫生》
CAS
CSCD
北大核心
2019年第4期385-387,共3页
Chinese Journal of Public Health
