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作者观察了b型流感杆菌多糖-白喉类毒素结合菌苗(PRP-D)对7～14月龄婴儿的安全性和免疫原性。888名健康婴儿参加了试验,这些婴儿以前均接种过3剂DTP。随机给80%的婴儿接种PRP-D,20%的婴儿接种盐水安慰剂,肌肉注射2次,每次0.5ml,间隔2个月。每次注射后15分钟内观察即刻反应,注射后6、24和48小时测量肛温。注射前和注射后1个月取血样,用Farr型放射免疫分析法测PRP抗体。第1次注射菌苗后收集了698人的反应发生率,第2次注射后收集了666人,两次注射后出现的反应没有明显差异。第1次注射安
The authors observed the safety and immunogenicity of the b-type bacilli-diphtheria toxoid conjugate vaccine (PRP-D) in infants 7 to 14 months of age. A total of 888 healthy infants were enrolled, all of whom had previously received 3 doses of DTP. Eighty percent of infants were randomized to receive PRP-D, 20% of infants were given saline placebo, and two intramuscular injections of 0.5 ml at 2-month intervals. Immediate response was observed within 15 minutes after each injection and rectal temperature was measured 6, 24 and 48 hours after injection. Blood samples were taken before injection and one month after injection, and PRP antibodies were measured by Farr radioimmunoassay. The incidence of the reaction was 698 after the first vaccine injection, 666 after the second injection, and there was no significant difference in response after the two injections. The first injection Ann