Rapid Licensure of a New, Inactivated Influenza Vaccine in the United States

被引:21
作者
Treanor, John J. [1 ]
Campbell, James D. [2 ]
Brady, Rebecca C. [3 ]
Keitel, Wendy A. [4 ]
Drame, Mamadou [5 ]
Jain, Varsha K. [6 ]
Innis, Bruce L. [6 ]
机构
[1] Univ Rochester, Sch Med & Dent, Rochester, NY 14642 USA
[2] Univ Maryland, Sch Med, Ctr Vaccine Dev, Baltimore, MD 21201 USA
[3] Cincinnati Childrens Hosp, Med Ctr, Cincinnati, OH USA
[4] Baylor Coll Med, Houston, TX 77030 USA
[5] GlaxoSmithKline Biol, Rixensart, Belgium
[6] GlaxoSmithKline Inc, King Of Prussia, PA USA
来源
HUMAN VACCINES | 2005年 / 1卷 / 06期
关键词
influenza; influenza vaccine; clinical trials; accelerated approval;
D O I
10.4161/hv.1.6.2376
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
Background: The unexpected problems at 1 of 2 US licensed manufacturers of trivalent inactivated influenza virus vaccine (TIV) in 2004 highlights the urgent need for additional vaccine sources. We evaluated a split virus TIV (Fluarix, GSK), to generate data supportive of a license application in the US. Methods: Healthy adults ages 18-64 years at four centers were randomly assigned to receive a single IM injection of Fluarix (n = 763) or placebo (n = 193) in double-blind fashion. Subjects were monitored for safety and serum hemagglutination-inhibition (HAI) titers determined before and 21 days after vaccination. Results: Vaccine was well tolerated, with only mild to moderate myalgias and injection site pain and redness being more common in vaccine than placebo recipients. Four-fold or greater increases in serum HAI titers were seen in 60%, 62% and 78% of vaccine recipients against the H1, H3, and B components of the vaccine, respectively, and post-vaccination titers of > 1:40 achieved in 98%, 99% and 99% of subjects, exceeding the prespecified criteria for acceptability for all three antigens. Conclusions: Fluarix has a safety and immunogenicity profile like other US-licensed inactivated influenza vaccines and should be effective when used to immunize US adults. Summary Line: the results of this study were pivotal for the rapid approval of Fluarix in the US for use in adults 18 years of age or older.
引用
收藏
页码:239 / 244
页数:6
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