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目的对国产大流行流感裂解疫苗进行Ⅰ期临床试验研究,观察其安全性。方法采用单中心、随机、双盲安慰剂对照设计,在16~60周岁健康成人中按1:1:1:1比例设流感疫苗7.5,15.0,30.0μg及安慰剂对照等4个试验组,分别在0,21 d肌内注射疫苗。结果在临床试验观察和随访期间未发现其他异常反应、偶合反应和任何有临床意义的严重不良事件。各组不良反应以1级局部反应为主,反应多在48 h内痊愈。3个剂量组不良反应发生率明显高于安慰剂对照组(2χ=25.282 5,P<0.0001)。30.0μg组局部和全身反应发生率最高,分别占78.79%和51.52%。第1针接种后反应发生率高出第2针100.00%。结论大流行流感裂解疫苗有较好的安全性,无3级及以上不良反应发生。
Objective To investigate the phase Ⅰ clinical trial of domestic-made pandemic flu vaccine and observe its safety. Methods A single-center, randomized, double-blind, placebo-controlled design was used to establish 4 experimental groups of influenza vaccines 7.5, 15.0, 30.0μg and placebo at a ratio of 1: 1: 1: 1 between 16 and 60 years old healthy adults. 0,21 d intramuscular injection of vaccine. Results No other abnormal reactions, coupling reactions and any clinically significant serious adverse events were observed during the clinical trial and follow-up. Each group of adverse reactions to a level of local reactions, mostly within 48 hours of recovery. The incidence of adverse reactions in the three dose groups was significantly higher than that in the placebo group (2χ = 25.282 5, P <0.0001). The incidence of local and systemic reactions was the highest in 30.0μg group, accounting for 78.79% and 51.52% respectively. After the first needle inoculation, the incidence of the reaction was 100.00% higher than that of the second needle. Conclusions The pandemic flu vaccine has good safety and no grade 3 and above adverse reactions occur.