A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age

Inclusion criteria

• ✓. Male or female ≥50 years of age (inclusive) at the time of randomization into the study.
• ✓. Able and willing to complete the informed consent process.
• ✓. Available for clinical follow-up through the last study visit at 7 months after the first study vaccination.
• ✓. In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator.
• ✓. Willing to have blood samples collected and used for research purposes.
• ✓. Able to provide proof of identity to the satisfaction of the study site personnel completing the enrollment process.
• ✓. Female subjects of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test at Screening and immediately prior to each vaccination and agree to use acceptable contraception, if heterosexually active. Female subjects who are not abstinent from heterosexual intercourse must agree to consistently practice contraception at least 7 days prior to vaccination and through their last study visit. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method (\[use condoms with or without spermicide\] or have undergone a vasectomy) from Day 1 through their last study visit. Note: A history of amenorrhea for at least 12 months without an alternative medical cause is required for a female to be considered postmenopausal in the study.
• ✓. Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).

Exclusion criteria