Mebel S, Rustenbach S, Giese H, Winkler C, Thilo W
Dev Biol Stand. 1977;34:207-11.
Clinical investigation of the reactivity of diphtheria-tetanus-pertussis (DTP) vaccines is a routine control in the GDR. This paper shows the results of the clinical control of 26 batches of DTP vaccine in comparison with animal tests (weight-gain-test, histamine-sensitizing test, dermonecrotic test). The animal tests gave no support to innocuity. The batches were tested on 427 children and passed the requirements for reactivity. After a storage for 2 years the control of 3 different batches was repeated. Two of them showed side reactions in children in spite of the fact that the results of the weight-gain test did not change.
对白喉-破伤风-百日咳（DTP）疫苗反应性的临床研究是民主德国的一项常规控制措施。本文展示了26批DTP疫苗临床对照的结果，并与动物试验（体重增加试验、组胺致敏试验、皮肤坏死试验）进行了比较。动物试验未证实其无害性。这些批次在427名儿童身上进行了测试，并通过了反应性要求。储存2年后，对3个不同批次进行了重复对照。其中两批尽管体重增加试验结果没有变化，但在儿童中出现了不良反应。
