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首页> 外文期刊>Journal of Korean medical science >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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Immunogenicity and safety of trivalent inactivated influenza vaccine: a randomized, double-blind, multi-center, phase 3 clinical trial in a vaccine-limited country.

机译：三价灭活流感疫苗的免疫原性和安全性：在疫苗有限的国家进行的一项随机，双盲，多中心，3期临床试验。

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摘要

Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center 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 in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.
机译：流感疫苗是控制流感及其并发症的主要方法。这项研究是在7所大学医院进行的一项3期，随机，双盲，对照，多中心试验，旨在评估灭活的，分裂的三价流感疫苗的免疫原性和安全性（GC501，绿十字公司，韩国龙仁市） ），该产品于2008年在韩国新制造。9月21日至26日，共招募了329名健康受试者进行免疫原性分析，而招募了976名受试者进行安全性分析。 GC501疫苗符合FDA和EMEA的标准，≥80％的受试者对所有三种亚型的接种后滴度均≥40，即使在老年人中也是如此。该疫苗具有良好的耐受性，仅有轻度的全身和局部不良事件。总之，GC501在年轻人和老年人中均表现出出色的免疫原性和良好的安全性。 GC501的许可可能是为将来的流感大流行做准备的重要基础。

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