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作者采用双盲法,用哥伦比亚和美国制备的Spf66疟疾疫苗,对150名6—11个月的冈比亚婴儿进行了Spf66安全性和免疫原性的试验。 将受试婴儿随机分成5组:组1:25名婴儿用1.0mg哥伦比亚制备的Spf66免疫;组2:25名,用0.5mg的同一疫苗免疫;组3:25名,用1.0mg美国制备的Spf66免疫;组4:25名,用0.5mg的同一疫苗免疫;组5:50名,用法国制备的灭活脊髓灰质炎疫苗(IPV)免疫,作为对照。各组受试婴儿在年龄、性别或民族方面无明显差别。
The authors tested Spf66 safety and immunogenicity in 150 Gambian infants aged 6-11 months using a double-blind, Spf-66 malaria vaccine prepared in Colombia and the United States. The infants were randomized into 5 groups: Group 1: 25 infants immunized with 1.0 mg of Spf66 made in Colombia; Group 2: 25 immunized with 0.5 mg of the same vaccine; Group 3:25, prepared with 1.0 mg of the United States Spf66; group 4:25, immunized with 0.5 mg of the same vaccine; group 5:50, immunized with Inactivated Polio Vaccine (IPV) prepared in France as a control. There was no significant difference in age, gender or ethnicity among infants in each group.