新生儿、婴儿、学童及青少年的卡介苗接种。第二部分：1331哥本哈根菌株疫苗的安全性。

BCG vaccination of neonates, infants, schoolchildren and adolescents. Part II: Safety of a vaccine with strain 1331 Copenhagen.

作者信息

Lehmann H G, Engelhardt H, Freudenstein H, Hennessen W, Quast U, Widmark R M

出版信息

Dev Biol Stand. 1979;43:133-6.

PMID:520665

Abstract

The safety of the vaccine could be assessed by three different investigations: a) During the dose finding study (part I) the vaccine showed good safety in all concentrations employed concerning reactions at the site of injection; palpable lymph node enlargement was common. There was one case of suppurative lymphadenitis amond the 262 children who were given the vaccine in the highest concentration (25 X 10(4) VU). b) Subsequent trials in the course of 21 months, when high risk persons could be vaccinated, revealed a rate of this complication in the 1:1,000 range, no case was reported among older persons. c) After the official approval of the vaccine (10 - 30 X 10(4) VU/ml) in the FRG 1 supp. lymphadenitis among 5,000 vaccinated newborns can be calculated.

摘要

疫苗的安全性可通过三项不同调查进行评估

a) 在剂量探索研究（第一部分）中，就注射部位的反应而言，该疫苗在所有使用浓度下均显示出良好的安全性；可触及的淋巴结肿大很常见。在接受最高浓度（25×10⁴VU）疫苗接种的262名儿童中，有1例发生了化脓性淋巴结炎。b) 在随后21个月的试验中，当高危人群可以接种疫苗时，这种并发症的发生率在千分之一左右，老年人中未报告病例。c) 在德国联邦共和国该疫苗正式获批（10 - 30×10⁴VU/ml）后，可以计算出5000名接种疫苗的新生儿中化脓性淋巴结炎的病例数。