Kuter B J, Weibel R E, Guess H A, Matthews H, Morton D H, Neff B J, Provost P J, Watson B A, Starr S E, Plotkin S A
Department of Clinical Research, Merck Sharp & Dohme Research Laboratories, West Point, PA 19486.
Vaccine. 1991 Sep;9(9):643-7. doi: 10.1016/0264-410x(91)90189-d.
A large double-blind, randomized, placebo-controlled trial of live attenuated Oka/Merck varicella vaccine was conducted among healthy children, 1-14 years of age. During the first varicella season, the efficacy of the vaccine among susceptible children was 100%1. During the second varicella season, 22 children were diagnosed with varicella; 21 cases in placebo recipients and one in a vaccine recipient. The overall efficacy of the vaccine through two varicella seasons was 98%. After the code for the study was broken, the original group of vaccine recipients continued to be followed for development of varicella. The estimated proportion of vaccine recipients who remained varicella-free at the end of 7 years was 95%. The 23 cases of varicella that occurred in vaccine recipients over the 7-year period were considerably milder than natural varicella. The average number of lesions was 53, 50% of the children had non-vesicular rashes, and 14% of the children had a temperature greater than or equal to 38.9 degrees C (102 degrees F), oral. The persistence of antibody in a subset of vaccine recipients followed for 6 years was 100%.
一项针对1至14岁健康儿童的大型双盲、随机、安慰剂对照的减毒活Oka/默克水痘疫苗试验展开。在第一个水痘季节，该疫苗在易感儿童中的有效性为100%。在第二个水痘季节，22名儿童被诊断出患有水痘；安慰剂接受者中有21例，疫苗接受者中有1例。经过两个水痘季节，该疫苗的总体有效性为98%。研究代码解密后，原疫苗接受组继续接受水痘发病情况的随访。在7岁末仍未感染水痘的疫苗接受者估计比例为95%。在7年期间疫苗接受者中出现的23例水痘病例比自然感染的水痘症状要轻得多。皮疹平均数量为53个，50%的儿童出现非水疱性皮疹，14%的儿童口腔温度高于或等于38.9摄氏度（102华氏度）。对一部分疫苗接受者进行了6年的随访，抗体持续存在率为100%。
