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  • Title: [Evaluation on the safety and immunogenicity of split influenza virus vaccine].
    Author: Zhang XM, Qi FC, Wang CY.
    Journal: Zhongguo Yi Miao He Mian Yi; 2009 Jun; 15(3):229-32. PubMed ID: 20084888.
    Abstract:
    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. CONCLUSION: 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.
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