Influenza vaccines conferring immunity against multiple strains of virus will be manufactured for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. It is hoped that these vaccines will confer broad immunity a "universal influenza vaccine" over a period of several years against multiple strains in contrast to seasonal products that are only useful for a single season. If these trials demonstrate safety and immunogenicity of this vaccine in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at large scale.
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|Liu, Jonathan; Mani, Sachin; Schwartz, Richard et al. (2010) Cloning and assessment of tumorigenicity and oncogenicity of a Madin-Darby canine kidney (MDCK) cell line for influenza vaccine production. Vaccine 28:1285-93|