Evaluation of clinical safety and immunogenicity of influenza split vaccine made in China

Objective The study was conducted to evaluate the safety and immunogenicity of influenza split vaccine.Methods Spot clinical trials were performed by grouped random sampling with imported vaccines of the same kind as the control group.The clinical reaction rate,antibody positive rate,protective rate and geometric mean titer(GMT)were taken into comparison.Results No post-inoculation pyrogenetic reaction were observed in both trial group and control group,the local reaction rates being 1.8% and 2.1%(P0.05),respectively,indicating slight reactions.The HI antibody positive rates of trial vaccine H1N1,H3N2 and B were respectively 93.6%,80.4% and 88.8%,while the rates of control vaccine H1N1,H3N2 and B were respectively 89.0%,77.3% and 86.6%.The total HI antibody positive rate in trial group was higher than in control group with statistical significance.The HI antibody increases of H1N1,H3N2 and B were averagely 23.9,8.6 and 12.9 times in trial group and 20.0,6.6 and 9.7 times in control group.The HI antibody increase in trial group was higher than in control group with statistical significance.The antibody protective rates of H1N1,H3N2 and B were respectively 94.8%,99.4% and 87.0% in trial group and 92.4%,100% and 83.0% in control group without statistical difference.Conclusion The influenza split vaccine made in China has no difference with imported vaccine of the same kind in pyrogenetic reactions,some indexes even better.Its post-inoculation antibody positive rate is higher and the increase of antibody titer larger.It has satisfying clinical safety and immunogenicity.