[Evaluation on the safety and immunogenicity of split influenza virus vaccine].
OBJECTIVE
To evaluate the safety and immunogenicity of split influenza virus vaccine made in changchun institute of biological products.


METHODS
Cluster samples were selected by random to carry out the single center, open clinical trial.


RESULTS
After one dose injection, the rate of local reaction were 0.6%, and fever rate was 4.52%. The majority of the people with fever were mild fever. The HI Antibody positive rate of Influenza H1N1, H3N2, and B type were 94.98%, 87.1% and 88.1%; Geometric mean titer (GMT) of the three types antibody increased 104.79, 69.97 and 40.83 times respectively. The antibody protective rate were 100%, 99.7%, and 98.4% respectively. There were statistical difference on the HI antibody positive rate, times of GMT increased, and the antibody protective rate among the three types of influenza vaccine.


CONCLUSIONS
It is safety of split influenza virus vaccine for the people who are > or = 3-years-old, which made in changchun institute of biological products, and with good immunogenicity.
Zhang
Xue-mei
XM
College of Animal Science and Veterinary Medicine, Jilin University, Changchun 130062, Jilin, China.
Qi
Feng-chun
FC
Wang
Chun-yi
CY
D000914:Antibodies, Viral / Q000276:immunology; D002675:Child, Preschool; D004341:Drug Evaluation; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007223:Infant; D009980:Influenza A virus / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology* / Q000517:prevention & control / Q000821:virology; D008297:Male
D000914:Antibodies, Viral; D007252:Influenza Vaccines