摘要
目的观察肠道病毒71型灭活疫苗(简称EV71疫苗)接种6~35月龄婴幼儿后的安全性。方法选择6~35月龄无接种禁忌且自愿接种的健康婴幼儿为研究对象。采用上臂三角肌肌内注射,间隔大于或等于28 d接种2剂次。现场观察每次接种后30 min内的即时反应,通过电话询问获得每次接种后3 d、28 d内的局部和全身反应,同时统计每名入组儿童是否全程接种2剂次EV71疫苗情况,将观察结果填写到每个受种者的《EV71疫苗接种观察记录表》中。采用Excel2013软件录入和分析。结果 2016年8月—2017年3月共收集到北京市朝阳区3 965名6~35月龄婴幼儿接种EV71疫苗信息,总不良事件发生率为1.16%(46/3 965)。完成2剂次全程接种的2 392名婴幼儿,不良事件发生率为1.21%(29/2 392),多数不良事件发生在30 min^3 d内,以发热为主。仅接种首剂次的1 237名婴幼儿,收集到16例不良事件;仅接种末剂次的336名婴幼儿,收集到1例不良事件。结论该EV71疫苗上市后在6~35月龄婴幼儿接种中具有良好的安全性。
Objective To evaluate the safety of a domestic enterovirus 71（EV71） vaccine being applied to infants andchildren among 6 to 35 months old. Methods The health volunteer without contraindication were accepted as the researchobjects, and thay received two doses of EV71 vaccine（intramuscular injection） with a 28-day interval. The adverse events wereinvestigated and recorded in 30 minutes, 3 days, and 28 days after each vaccination. At the same time, whether completing thewhole course of vaccination（2 does of EV71 vaccine） were also investigated. Results A total of 3 965 infants and childrenwere vaccinated from August 2016 to March 2017. The overall incidence of adverse reactions was 1.16%（46/3 965）. Thenumber of people who got two doses of vaccination was 2 392, and 29 people had adverse events（1.21%）. Of the all 29 adverseevents, 23 occurred after the first vaccination and 4 occurred after the second vaccnation. Most of the adverse events occurredfrom 30 minutes to 3 days, and the most common adverse events were fever. Among 1 237 persons who received only the firstvaccination, 16 had adverse events, and among 336 people who received only the second vaccination, one had an adverse event.Conclusion The safety of the domestic EV71 inactivated vaccine is good in infants and children aged 6 to 35 months old.
出处
《中国热带医学》
CAS
2017年第12期1234-1236,1246,共4页
China Tropical Medicine
关键词
手足口病
EV71
灭活疫苗
安全性
hand foot and mouth disease
enterovirus 71
inactivated vaccine
safety
