Hedenskog S, Granström M, Olin P, Tiru M, Sato Y
Am J Dis Child. 1987 Aug;141(8):844-7. doi: 10.1001/archpedi.1987.04460080030021.
We compared a monocomponent pertussis toxoid vaccine preparation (JNIH-7) in a double-blind, randomized study with another component vaccine (JNIH-6) containing pertussis toxoid and filamentous hemagglutinin in equal proportions. Monocomponent pertussis toxoid vaccines have not been tested previously in children. This trial comprised 255 previously nonimmunized children 6 to 10 months old who were given two 0.5-mL subcutaneous injections of either vaccine four to five weeks apart. Prevaccination and postvaccination serum samples from 235 infants showed an antitoxin seroconversion rate of 100% in both groups. Adverse reactions were few and mild, with local reactions occurring more often after administration of the second dose and among recipients of the two-component vaccine (P less than .05).
在一项双盲随机研究中，我们将一种单组分百日咳类毒素疫苗制剂（JNIH - 7）与另一种等比例含有百日咳类毒素和丝状血凝素的组分疫苗（JNIH - 6）进行了比较。单组分百日咳类毒素疫苗此前尚未在儿童中进行过测试。该试验纳入了255名6至10个月大、此前未接种过疫苗的儿童，他们在相隔四至五周的时间里接受了两次0.5毫升皮下注射，两种疫苗各注射一次。235名婴儿接种疫苗前和接种后的血清样本显示，两组的抗毒素血清转化率均为100%。不良反应很少且轻微，局部反应在接种第二剂后更常出现，并且在接种双组分疫苗的受种者中更常见（P小于0.05）。
