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

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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]).