[Abstract] To evaluate the safety and immunogenicity of a trivalent split influenza virus vaccine produced by Sinovac Biotech Co., Ltd.
[Author] LI Yan-ping, LI Rong-cheng, CHEN Jiang-ting, et al.
[key words] Split influenza virus vaccine; Safety; Immunogenicity
Objective To evaluate the safety and immunogenicity of a trivalent split influenza virus vaccine produced by Sinovac Biotech Co., Ltd.
Methods The clinical trial was carried out by Guangxi Zhuang Nationality Municipality Center for Disease Control and Prevention in Nanning City and Liucheng County of Guangxi from June 20, 2003 to September 10, 2003. 1332 subjects were screened from the over-6-month variedly-aged healthy persons. After vaccination, adverse events of the subjects were observed and the different types antibodies of the subjects were tested by the micro-hemagglutination inhibition(HI) test.
Result One case of Redness and swelling occurred in the trial group and control group, respectively. The phenomenas disappeared within the 72-hour at all. The rate of the fever was 3.21% and 6.25% in the trial group and the control group, respectively. The results showed significant statistical difference. Other adverse events weren’t detected. 734 subjects in the trial group and 163 subjects in the control group were tested by HI test. The anti-HI seroconversion rate were 50.0～84.2％ and 57.7～84.0％,respectively. The Anti-HI GMT of the three influenza virus (sub-) types increase from 4.2 to 11.4 folds and 5.7 to11.6 folds for the trial group and the control group, respectively, and statistical difference was not significant. The immunogenicity of the trial vaccine satisfied the European Pharmacopoeia standards.
Conclusion These results indicated that the trial-Anflu vaccine has excellent safety and immunogenicty and may be suited for wide use.
Table 1
Anflu is proved to have better safety than the control vaccine among the 1332 subjects including children, adults and elders.
Table 2
Table 3
Table 4
Anflu is proved to have excellent immunogenicity by the randomized control trial among the 897 subjects.
Original: Chinese Journal of Vaccines and Immunization, 2005, 11(5): 343-347
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