Meurice F, De Bouver J L, Vandevoorde D, Woods S, Bogaerts H
Clinical Research and Development Dept., Smithkline Beecham Biologicals S.A., Rixensart, Belgium.
J Infect Dis. 1996 Nov;174 Suppl 3:S324-9. doi: 10.1093/infdis/174.supplement_3.s324.
An Oka strain varicella vaccine developed by SmithKline Beecham Biologicals in the early 1980s is registered for immunization of high-risk groups in nine European countries. Because the preparation must be stored at -20 degrees C, it was reformulated to facilitate its use for general vaccination in healthy children with storage at 2-8 degrees C for 2 years. Studies using production lots of the reformulated vaccine in approximately 1400 healthy children are summarized. During the 42-day follow-up, no vaccine-related serious adverse events were reported. Unsolicited reactogenicity rates were low: 14.2% in children ages 9-36 months (the main target age group for the vaccine). Seroconversion rates were 98.6% after a single dose. Consistent reactogenicity and immunogenicity were observed across vaccine lots. After efficacy is demonstrated in other studies, widespread use of this vaccine will prevent a common and potentially serious childhood illness.
20世纪80年代初由史克必成生物制品公司研发的一种Oka株水痘疫苗在9个欧洲国家被注册用于高危人群的免疫接种。由于该制剂必须储存在-20摄氏度，因此对其进行了重新配方，以便于在健康儿童中进行常规接种，并可在2-8摄氏度储存2年。总结了在约1400名健康儿童中使用重新配方疫苗生产批次的研究情况。在42天的随访期间，未报告与疫苗相关的严重不良事件。自发反应原性率较低：在9至36个月龄的儿童（该疫苗的主要目标年龄组）中为14.2%。单剂接种后的血清转化率为98.6%。在不同疫苗批次中观察到一致的反应原性和免疫原性。在其他研究证明其有效性后，这种疫苗的广泛使用将预防一种常见且可能严重的儿童疾病。
