【摘要】 目的比较乙型脑炎减毒活疫苗和Vero细胞乙型脑炎纯化疫苗基础免疫、加强免疫及两种疫苗接种后的不良反应。方法选择两个县的两组8月～3岁的健康婴幼儿共1864名接种不同疫苗,观察接种前和接种后6h、24h、48h、72h腋下温度、注射部位红肿直径和全身皮疹发生情况,按国家食品药品监督管理局“国食药监注[2005]493号《预防用疫苗临床试验不良反应分级标准指导原则》”进行不良反应分级。结果疫苗接种后不良反应以发热为主达125人,其次为全身皮疹17人,注射部位红肿7人,未见潜在生命威胁的不良反应,所有接种反应均为一过性。乙型脑炎减毒活疫苗不良反应发生率为5.21%(基础免疫4.69%,加强免疫5.72%),Vero细胞乙型脑炎纯化疫苗不良反应发生率为8.75%(基础免疫7.10%,加强免疫10.40%),两组不良反应的发生率差异有统计学意义。更多还原

【Abstract】 Objective For comparison of adverse reaction after both basic and booster immunization separately with JE live attenuated vaccine and vero cell-derived one Methods A total of 1,864 healthy babies aged 8 months to 3 years were recruited in 2 counties of Hunan Province. Axillary temperature, diameter of swelling on injection site as well as skin rash was checked before vaccination and in 6h, 24h, 48h and 72h of vaccination. The adverse reaction was graded in accordance with the Instructive Principle for Standard Grading of Adverse Reaction in Clinical Trial of Vaccine for Preventive Use issued by China State FDA in document GSYJZ[2005]493. Result One hundred twenty-five children were characterized with fever in adverse reaction after being vaccinated, followed by 17 with skin rash all over the body, and 7 with red swelling on injection site. None reaction was found potentially life-threatening and all was transient. The occurrence rate of adverse reaction by JE live attenuated vaccine was 5.21% (4.69% in basic immunization, and 5.72% in booster), that by vero cell-derived one was 8.75% (7.10% in basic immunization, and 10.40% in booster), showing a statistical significance of difference in the two group.更多还原