科研之友
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摘要
A double-blind, randomized, controlled trial involving 706 adults was conducted to evaluate the immunogenicity and safety of different dosages of whole-virion or split-virion H1N1 influenza vaccines with or without aluminum adjuvant. A rapid and strong immune response was induced at day 14 after the first injection. The seroprotection rates ranged from 72.7% (95% confidence interval [CI], 62.7%-81.1%) for 5-mu g whole-virion aluminum formulation to 97.0% (95% CI, 90.9%-99.7%) for 30-mu g split-virion nonaluminum formulation. All formulations were well tolerated. The incidences of mild, moderate, and severe reactions were 71 (10.1%), 15 (2.1%), and 1 (0.1%) of 706 reactions, respectively. The 15-mu g split-virion formulation had the best immunogenicity and safety.
- 出版日期2010-9-1
- 单位中国食品药品检定研究院; 中国疾病预防控制中心
