Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine

Inclusion Criteria

• Healthy, medically stable adult males or females ≥ 50 to ≤ 70 years of age at screening.
• Willing and able to give informed consent prior to study enrollment.
• Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
• Participants must have been baseline seropositive to SARS-CoV-2 defined as either:
• Having completed a primary vaccination series against SARS-CoV-2 with an authorized COVID-19 vaccine with receipt of second/final dose of authorized vaccine ≥ 8 weeks prior to enrollment (first study vaccination).

OR

• Previously infected with SARS CoV-2 ≥ 8 weeks prior to enrollment (first study vaccination).

Note: Baseline SARS-CoV-2 serostatus determination at screening will be based on vaccination documentation (eg, vaccination card or vaccination registry) or participants' report of a previous SARS-CoV-2 infection.

• Women of childbearing potential (defined as any female participant who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.
• Condoms (male or female) with spermicide (if acceptable in-country)
• Diaphragm with spermicide
• Cervical cap with spermicide
• Intrauterine device
• Oral or patch contraceptives
• Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
• Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
• Participants must be healthy and medically stable, as determined by the investigator (based on a review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Participants must have a body mass index (BMI) of 17 to 34 kg/m2, inclusive, at screening. Vital signs must be within medically acceptable ranges prior to the first vaccination.
• Participants must agree to not participate in any other SARS-CoV-2 or influenza prevention or treatment studies for the duration of the study. Note: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.

Exclusion Criteria

• Any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care.
• Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator.
• Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
• Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or SARS-CoV-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable.
• Participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection.
• Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection.
• History of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products conta