Immunogenicity and Safety of Trivalent Inactivated Influenza Vaccine: A Randomized, Double-Blind, Multi-Center, Phase 3 Clinical Trial in a Vaccine-Limited Country
Immunogenicity and Safety of Trivalent Inactivated Influenza Vaccine: A Randomized, Double-Blind, Multi-Center, Phase 3 Clinical Trial in a Vaccine-Limited Country
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DOI：
10.3346/jkms.2011.26.2.191
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发表时间：
2011-02-01
影响因子：
4.5
通讯作者：
Kim, Woo Joo
中科院分区：
文献类型：
--
作者：
Song, Joon Young;Cheong, Hee Jin;Kim, Woo Joo
流感疫苗是控制流感及其并发症的主要方法。本研究是一项在7所大学医院进行的III期、随机、双盲、对照、多中心试验，旨在评价2008年在韩国新生产的灭活、裂解、三价流感疫苗（GC 501，绿色Cross Corporation，永仁，韩国）的免疫原性和安全性。9月21日至26日，共招募329例健康受试者进行免疫原性分析，976例受试者进行安全性分析。GC 501疫苗符合FDA和EMEA标准，>= 80%的受试者在接种后所有三种亚型的滴度均>= 40，即使在老年人中也是如此。该疫苗耐受性良好，仅发生轻度全身和局部不良事件。总之，GC 501在年轻人和老年人中均显示出优异的免疫原性和良好的安全性。GC501的许可可能是未来流感大流行准备的重要基础。
Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multicenter trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with >= 80% of subjects achieving post-vaccination titers >= 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile ill both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.