Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old,
inclusive, will be enrolled over a 5-month period into this multicenter, randomized,
double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study
and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted
vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular
subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given
with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2
doses separated by approximately 21 days.