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目的为了评价3价流行性感冒(流感)裂解疫苗安尔来福TM的安全性和免疫原性。方法于2003年6~11月在广西壮族自治区南宁市和柳城县进行以进口同类疫苗为对照的临床研究。受试者为>6个月~>60岁健康人群1 332人,接种疫苗后对受试者进行不良反应观察,应用微量血凝抑制(HI)试验对受试者血清进行抗体分型检测。结果试验疫苗组与对照疫苗组各有1例出现接种部位红肿,均在72h内消失;试验组与对照组发热反应率分别为3.21%(35/1 092)、6.25%(15/240),差异有显著的统计学意义。未见其它不良反应发生。试验组和对照组各有734人和163人检测了HI抗体,结果各型HI抗体总阳转率分别为50.0%~84.2%和57.7%~84.0%,抗体几何平均滴度分别增长4.2~11.4倍和5.7~11.6倍,差异均无显著的统计学意义。结论试验疫苗的免疫效果达到欧盟标准,表明流感裂解疫苗安尔来福TM的安全性、免疫原性良好,适于推广使用。
Aim To evaluate the safety and immunogenicity of the trivalent influenza (influenza) split vaccine, Methods From June to November 2003, clinical trials of imported similar vaccines were conducted in Nanning City and Liucheng County of Guangxi Zhuang Autonomous Region. The subjects were 1 332 healthy people> 6 months to over 60 years old. After vaccination, adverse reactions were observed in the subjects. Serum samples were tested for anti-HBs by HI test. Results In the experimental group and the control group, one of the vaccinated group and the control group had inflamed swollen sites, all disappearing within 72 hours. The rates of fever in experimental group and control group were 3.21% (35/1 092), 6.25% (15/240) The difference was statistically significant. No other adverse reactions occurred. HI antibody was detected in 734 and 163 control subjects respectively. The results showed that the total positive conversion rates of HI antibody were 50.0% -84.2% and 57.7% -84.0%, respectively, and the geometric mean antibody titers increased by 4.2-11.4 Times and 5.7 ~ 11.6 times, no significant difference was statistically significant. Conclusion The immune effect of the test vaccine meets the EU standards, indicating that the safety of the influenza cleavage vaccine, Aeroflex ™, is good and the immunogenicity is good, which is suitable for popularization and utilization.