Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine.
Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine.
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新型三价灭活流感疫苗的免疫原性、安全性和一致性。
DOI：
10.1016/j.vaccine.2008.05.024
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发表时间：
2008
期刊：
影响因子：
5.5
通讯作者：
Edwards,
中科院分区：
文献类型：
--
作者：
Talbot,HKeipp;Keitel,Wendy;Cate,ThomasR;Treanor,John;Campbell,James;Brady,RebeccaC;Graham,Irene;Dekker,CorneliaL;Ho,Dora;Winokur,Patricia;Walter,Emmanuel;Bennet,Jillian;Formica,Neil;Hartel,Gunter;Skeljo,Maryanne;Edwards,
为了增加可用的流感疫苗供应，进行了一项III期研究，以评估由CSL Limited生产的新型三价灭活流感疫苗的免疫原性、安全性和一致性。健康成年人（年龄18-64岁）随机接受来自含硫柳汞的多剂量小瓶的单剂量TIV、来自不含硫柳汞的预充式注射器的TIV或安慰剂。在TIV接种者中，97.8%的接种后抗H1N1效价≥40，99.9%的接种后抗H3 N2效价≥40，94.2%的接种后抗B型流感效价≥ 40。在接种任一TIV表现的疫苗后，很少观察到局部或全身不良事件。TIV具有良好的耐受性和免疫原性。
To augment the available influenza vaccine supply, a phase III study was conducted to evaluate the immunogenicity, safety, and consistency of a new trivalent inactivated influenza vaccine manufactured by CSL Limited. Healthy adults (ages 18–64) were randomized to receive either a single dose of TIV from multi-dose vials with thimerosal, TIV from pre-filled syringes without thimerosal, or placebo. Of the TIV recipients, 97.8% achieved a post-vaccination titer ≥40 against H1N1, 99.9% against H3N2 component, and 94.2% against influenza B. Few local or systemic adverse events were noted after vaccination with either TIV presentation. TIV was well tolerated and immunogenic.