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目的评价加拿大Shire公司生产的流行性感冒(流感)裂解疫苗的安全性和免疫原性。方法按整群随机抽样原则,以进口同类疫苗作为对照开展现场临床试验;比较两种流感疫苗免疫后临床反应率、抗体阳转率、保护率及几何平均滴度(GMT)。结果试验组发热反应率(3.69%)及局部反应率(1.75%)与对照组相比较,两组间差异无统计学意义。试验组、对照组免疫后H1N1、H3N2、B型抗体阳转率分别为96.8%、95.8%、52.3%和92.3%、90.2%、62.3%;结果显示两种流感疫苗间阳转率差异有统计学意义。试验组和对照组的H1N1、H3N2及B(亚)型抗体GMT平均增长倍数分别为22.4、16.8、8.2倍和21.2、12.5、7.4倍;试验组免疫后H1N1、H3N2、B型抗体保护率(99%、99%、53.9%)与对照组免疫后三型保护率(96.2%、98.4%、62.3%)差异无统计学意义。结论加拿大Shire公司生产的流感裂解疫苗发热反应和局部反应与进口同类疫苗无差异,临床安全性良好;免疫后抗体阳转率较高,抗体滴度上升幅度较大,具有良好的免疫原性。
Objective To evaluate the safety and immunogenicity of the influenza (influenza) split vaccine produced by Shire Canada. Methods According to the principle of random sampling in cluster, a field clinical trial was conducted to import the same vaccine as control. The clinical response rate, antibody positive rate, protection rate and geometric mean titer (GMT) of two kinds of influenza vaccines were compared. Results The fever response rate (3.69%) and local response rate (1.75%) in the experimental group were not significantly different from those in the control group. The positive rates of H1N1, H3N2 and B antibody immunization were 96.8%, 95.8%, 52.3% and 92.3%, 90.2% and 62.3% in the test group and the control group respectively. The results showed that there was statistical difference between the positive rates of the two influenza vaccines Significance of learning. The average growth of GMT of H1N1, H3N2 and B (sub) type antibody in test group and control group were 22.4, 16.8, 8.2 times and 21.2, 12.5, 7.4 times respectively. The protection rate of H1N1, H3N2 and B antibody 99%, 99%, 53.9%) were not significantly different from those of control group (96.2%, 98.4%, 62.3%). Conclusion The fever response and local reaction of flu-splitting vaccine produced by Shire in Canada showed no difference with imported similar vaccines, and the clinical safety was good. After immunization, antibody positive rate was higher and the antibody titer increased greatly, which showed good immunogenicity.