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本文比较了b型流感杆菌荚膜多糖菌苗(PRP)和一种新型的多糖-白喉类毒素结合菌苗(PRP-D)的安全性和免疫原性。受试者为585名15～24月龄健康幼儿,男女各半,其中80%白种人,13%黑种人,7%其他肤色人,受试者分布于美国5个州的6个研究中心。作者选用美国Connaught药厂制备的PRP和PRP-D菌苗。后者5批,每人份0.5ml中含PRP和白喉类毒素各20μg;前者3批,每人份0.5ml中含PRP 20μg,通过加热处理使多糖平均分子量0.6;1批PRP菌苗不经加热处理,有7%的多糖混合物分子量>12×10~6。用双盲随机方法给受试者肌肉注射
This article compared the safety and immunogenicity of the Influenza b-type capsular polysaccharide vaccine (PRP) with a novel polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D). The subjects were 585 healthy children aged 15 to 24 months of age, half male and half female, 80% Caucasian, 13% Black and 7% other color. The subjects were distributed in 6 studies in 5 U.S. states center. The authors selected the United States Connaught Pharmaceutical Factory prepared PRP and PRP-D vaccine. The latter 5 batches, each containing 0.5ml of PRP and diphtheria toxoid each 20μg; the former three batches, each containing 0.5ml PRP 20μg, by heat treatment polysaccharide average molecular weight 0.6; 1 batch of PRP bacteria Seedlings without heat treatment, 7% of the polysaccharide mixture molecular weight> 12 × 10 ~ 6. Subjects were injected intramuscularly in a double-blind, randomized manner