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目的评价国产水痘减毒活疫苗的安全性和免疫原性。方法选择1～12岁的健康儿童以随机方式接种国产和进口冻干水痘减毒活疫苗,依据《预防接种手册》观察安全性,用膜抗原荧光抗体(FAMA)法测定血清中的抗水痘病毒抗体阳性率和抗体水平。结果国产疫苗和进口对照疫苗局部反应率分别为5.3%和6.0%,全身反应为13.0%和8.0%,差异均无统计学意义;试验疫苗和对照疫苗免疫后水痘抗体阳性率分别为98.3%和99.4%;抗体GMT为1:146.34和1:153.58,均无组间差异。结论试验疫苗与进口对照疫苗具有同样良好的安全性和免疫原性。
Objective To evaluate the safety and immunogenicity of live attenuated domestic varicella vaccine. Methods Healthy children from 1 to 12 years old were randomly inoculated with live-attenuated vaccines of domestic and imported freeze-dried varicella tablets. The vaccination manual was used to observe the safety and the anti-varicella virus in serum was detected by FAMA Antibody positive rate and antibody level. Results The local response rates of domestic vaccine and imported control vaccine were 5.3% and 6.0% respectively, and the systemic reactions were 13.0% and 8.0% respectively. There was no significant difference between the two groups. The positive rate of chickenpox antibody was 98.3% 99.4%; antibody GMT was 1: 146.34 and 1: 153.58, no differences between groups. Conclusions The test vaccine has the same good safety and immunogenicity as the imported control vaccine.