[Safety and immunogenicity of split vaccines of influenza viruses].
OBJECTIVE
To evaluate the safety and immunogenicity of influenza split vaccine.


METHODS
According to the criteria of No.2002SL0043, instruction of application for new drug in clinical trial issued by the State Food and Drug Administration, 876 healthy persons were divided at random into vaccine group and control group. The trial was performed with the double blind method. Local and systemic adverse reactions were observed within 3 days after the vaccine group subjects were vaccinated. The antibody response to vaccines was detected with hemagglutination inhibition (HI) test. Numbers of seroconversions and HI titers greater than or equal to 40, as well as the mean geometric titer increase in HI were analyzed.


RESULTS
There was no significant difference in local and systemic adverse reaction between vaccine and control groups. Meanwhile there was also no significant difference in seroconversions and protective level between two groups. However, there was obvious difference in mean geometric titer increase of antibody against H1N1 virus, while there was no significant difference in that of antibodies to H3N2 and type B viruses.


CONCLUSIONS
The safety and immunogenicity of both vaccines are excellent.
Zhu
Chang-lin
CL
Changchun Changsheng Life Sciences Limited, Changchun 130012, China.
Fang
Han-hua
HH
Zhu
Feng-cai
FC
Wang
Yu-qi
YQ
Wu
Xiao-li
XL
Xue
Feng-bo
FB
Shen
Yan-jie
YJ
Lian
Jin-zhang
JZ
D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005334:Fever / Q000139:chemically induced; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D009980:Influenza A virus / Q000276:immunology*; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects / Q000145:classification / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008875:Middle Aged; D012449:Safety; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000145:classification / Q000276:immunology
D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated