摘要
目的评价b型流感嗜血杆菌(Hib)结合疫苗在3月龄～5岁婴幼儿中的安全性和免疫原性。方法采用随机、盲态、同类制品平行对照设计,对1～5岁、7～12月龄和3～6月龄组婴幼儿分别接种b型流感嗜血杆菌结合疫苗,观察局部及全身反应,并检测血清抗体滴度。结果 3个年龄组接种Hib结合疫苗后不良反应总发生率为24.9%,1～5岁、7～12月龄和3～6月龄组不良反应总发生率分别为19.8%、24.9%和30.0%,其中3～6月龄试验组和对照组间不良反应总发生率差异有统计学意义(P=0.029 1),试验组高于对照组,其余2个年龄组试验组和对照组间不良反应总发生率差异无统计学意义(P=0.737 8和P=0.757 8)。Hib结合疫苗免后阳转率达98.5%。达保护性水平的比例为95.6%,免后抗-Hib平均水平(GMT)为8.77μg/ml。结论 b型流感嗜血杆菌结合疫苗接种3月龄～5周岁受试者达到良好的免疫效果,接种后具有良好的安全性及耐受性。
Objective To evaluate the safety and immunogenicity of Haemophilus influenza type b conjugate vaccine used in the children from 3 rhonths to 5 years old. Methods Under random, biind and parallel trial design, children of 1 -5years, 7 -12 months and 3 -6 months were immunized with Haemophilus influenza type b conjugate vaccine. Lo- cal and system adverse reactions were observed and serum antibody was determined too. Results The overall incidence of adverse reaction was 24.9% ; adverse reaction incidences of 1 -5 years old, 7 -12 months and 3 -6 months were respectively 19.80/o , 24. 9% and 30. 0%. For 3 -6 months of age, the incidence of adverse reaction in test group was higher than that of control group （ P = 0. 029 1 ）. The adverse reaction rates of the rest two groups showed no significant difference （P =0. 7378, P =0. 7578, respectively）. The positive conversion rate in test group was 98.5%. Rate of an- tibody that achieved protective level was 95.6% and the anti - PRP GMT achieved 8.77μg,/ml. Conclusion Hae- mophilus influenza type b conjugate vaccine used in the children from 3 months to 5 years old can yield effective immu- nogenieity. The safety and tolerance is also acceptable.
出处
《职业卫生与病伤》
2013年第1期40-42,共3页
Occupational Health and Damage
关键词
B型流感嗜血杆菌结合疫苗
不良反应
免疫原性
可信区间
Haemophilus influenza type b conjugate vaccine
adverse reaction
immunogenicity
confidence interval
