儿童和老年人群接种双价肾综合征出血热纯化疫苗(Vero细胞)安全性观察

目的评价双价肾综合征出血热纯化疫苗(Vero细胞)应用于6～15岁及60岁以上人群的接种安全性。方法对知情同意的6岁以上三个年龄组500名健康人群按2∶1∶2的比例非随机接种双价肾综合征出血热纯化疫苗(Vero细胞),采用同一批疫苗接种16～60岁人群作为对照组,观察6～15岁及60岁以上人群试验疫苗接种反应。结果6～15岁儿童组、16～60岁成人组在初次疫苗接种后中度全身(体温)反应率均为1.00%,6～15岁儿童组在初次疫苗接种后中度局部(局部红肿)反应率为0.50%;6～15岁儿童组、16～60岁成人组在第二次疫苗接种后没有观察到中、强度(体温、局部红肿)反应;>60岁老人组在初次和第二次疫苗接种后均没有发现中、强度反应。三组的全身、局部反应发生率均差异无显著性(P>0.05)。结论双价肾综征出血热纯化疫苗(Vero细胞)在6～15岁儿童组和>60岁老人组人群接种具有良好的安全性。

Observation of security of hemorrhagic fever with renal syndromeⅡpurified vaccine(Vero cells)inoculating in children and the elderly

Objective To evaluate the security of Hemorrhagic Fever with Renal Syndrome(HFRS)Ⅱ purified vaccine(Vero cells)inoculating in 6-15-year-old crowd and the people over the age of 60.Methods500 healthy people of 6-year-old and above were inoculated in HFRS Ⅱ purified vaccine(Vero cells)Non-randomized according to the ratio of 2∶1∶2,as a control group,16-60-year-old crowd inoculated in the vaccine of same Lot No.then observed the vaccination reaction.ResultsThe moderate body(body temperature)response rate was 1.00% both in 6-15-year-old crowd and in 16-60-year-old crowd after the initial vaccination,and the local moderate(local swelling)response rate was 0.50% in 6-15-year-old crowd;Moderate and serious(temperature,local swelling)response were neither observed in 6-15-year-old crowd nor in 16-60-year-old crowd after the second vaccination;Neither moderate response nor the serious was observed in people over the age of 60 after the two vaccination.There was no significant difference in the rate of systemic and local reaction of three groups(P>0.05).ConclusionHFRS Ⅱ purified vaccine(Vero cells)has good security in 6-15-year-old crowd and the people over the age of 60.