Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects

Inclusion criteria

Inclusion * Agrees to comply with the study procedures and provides written informed consent * 18 to 64 years of age * Body mass index between 18 and 30 kg/m2 * Negative urine pregnancy test at the Screening visit and the day of each vaccination. * Female subjects must either be of non-childbearing potential or use highly effective methods of contraception from at least 2 months before the Screening Visit through 3 weeks post last vaccination * In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination Exclusion * Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care * Administration of an investigational product within 45 days * Women who are pregnant or breastfeeding, or plan to become pregnant during the study * Prior administration of investigational agent using formulations similar to VAL-506440 * History of a serious reaction to prior influenza vaccinations * History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine * Administration of any live attenuated vaccines within 4 weeks before enrollment, inactive vaccines within 2 weeks before enrollment, or plans to any vaccine within the vaccination period * Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination * Any chronic administration of immunosuppressant or other immune-modifying drugs within 6 months prior to administration of study vaccine * Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. * Any acute disease at the time of enrollment * Any bleeding risk or thromboembolic event or any related medical history * Regular alcohol consumption \> 3 units/day, or current user of any illicit drugs, or has a history of drug/alcohol abuse with 1 year of screening or has a positive urine drug/alcohol test at screening * Persons employed in a capacity that involves handling poultry or wild birds * Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies within 4 weeks before administration of the first vaccination, throughout the study * Had major surgery or donation of blood or blood products within 4 weeks of dosing * Current smoking of more than 10 cigarettes (or equivalent amount of tobacco) per day, and within 3 months prior to Screening * Subject is an employee of the Sponsor or CRO involved in the study. * Vulnerable subjects (e.g., a subject kept in detention). * Any condition, that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of the study results * History of autoimmune disease * Inadequate Liver Function as defined by AST, ALT, GGT, alkaline phosphatase and bilirubin \> 1.5xULN * Known allergy or history of anaphylaxis or other serious adverse reactions to any of the constituents of the study vaccine