A series of pharmacology, safety and toxicology studies have been carried out in two animal species, the mouse and the rat. Pharmacology studies have demonstrated that FLU-v is able to generate both a cell mediated and humoral response in vaccinated animals and that the cell mediated response is enhanced when FLU-v is injected together with an adjuvant. A safety pharmacology study in rats demonstrated that FLU-v had no biologically relevant effects on cardiovascular or respiratory parameters when administered subcutaneously alone or in combination with the adjuvant.