CSL LIMITED INACTIVATED INFLUENZA VACCINE IN ADULTS > 18 TO < 65 YEARS OF AGE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项临床试验是为了满足食品和药物管理局(FDA)加快CSL流感疫苗在美国批准的要求。为了获得健康成人的适应症，CSL必须进行一项安慰剂对照研究，以满足所有3种流感疫苗株的明确免疫原性结果。 为了让CSL在下一个北半球流感季节(2007/2008)及时获得许可、生产和销售其疫苗，这项试验需要在2006年年中开始。疫苗及相关生物制品咨询委员会(疫苗及相关生物制品咨询委员会)建议纳入55428/2007年北半球疫苗的流感病毒株未能及时提供，无法为这次试验生产研究疫苗。因此，研究中的疫苗含有世卫组织为2006年南半球流感季节推荐的流感病毒株。北半球2006/2007和南半球2006毒株的不同之处仅在于H3N2毒株(A/Wisconin/67/2005)与(A/New York/55/2004-NYMC X-157)。 总体而言，已经进行了26项临床研究来评估CSL疫苗。尽管该疫苗尚未在疗效研究中进行正式测试，但人们普遍认为，满足三价灭活流感疫苗的免疫原性标准可能会作为一种替代标记，很可能预测临床益处。CSL流感疫苗的商业经验包括在澳大利亚、欧洲(包括英国和瑞典)、非洲(南非)、东南亚和南美洲的16个国家和地区注册。这相当于自1985年以来销售的大约3900万剂疫苗的安全监测数据(2400万剂CSL流感疫苗[含硫柳汞]和1500万剂CSL流感疫苗[不含硫柳汞])。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This clinical trial is being conducted to satisfy the Food and Drug Administration (FDA) requirements for accelerated approval of the CSL Influenza Vaccine in the US. In order to obtain an indication for healthy adults, CSL must conduct a placebo-controlled study to meet defined immunogenicity outcomes for all 3 influenza vaccine strains. In order for CSL to license, manufacture and market its vaccine in time for the next Northern Hemisphere Influenza season (2007/2008), this trial needed to commence by mid-2006. The Influenza strains recommended by the Vaccines and Related Biological Products Advisory Committee (IDRAC 55428) (VRBPAC) for inclusion in the Northern Hemisphere vaccine for 2006/2007 was not be available in time to manufacture the study vaccines for this trial. Therefore, the study vaccines contained the influenza strains recommended by the WHO for the 2006 Southern Hemisphere Influenza season. The Northern Hemisphere 2006/2007 and the Southern Hemisphere 2006 strains differ only in the H3N2 strain (A/Wisconsin/67/2005) Vs (A/New York/55/2004-NYMC X-157). Overall, 26 clinical studies have been conducted to evaluate the CSL vaccine. Although the vaccine has not been formally tested in efficacy studies, it is generally accepted that satisfying the immunogenicity criteria for trivalent inactivated influenza vaccines may act as a surrogate marker that is likely to predict clinical benefit. The commercial experience with the CSL Influenza Vaccine includes registration in 16 countries throughout Australia, Europe (including the United Kingdom and Sweden), Africa (South Africa), Southeast Asia, and South America. This equates to safety surveillance data for approximately 39 million doses of the vaccine sold since 1985 (24 million doses of CSL Influenza Vaccine [thimerosal-containing] and 15 million doses of CSL Influenza Vaccine [thimerosal-free]).