Study of a Combination SARS-CoV-2 Recombinant Spike and High-Dose Inactivated Influenza Vaccine With Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older

Inclusion criteria

Inclusion criteria to be checked at Screening Visit:

• Aged 60 years or older on the day of inclusion
• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all study procedures
• Participant must be able to receive an injection in the deltoid muscle of both arms
• Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine Inclusion criteria to be checked at Visit 1 (D01)
• Aged 60 years or older on the day of inclusion
• Participants who are healthy or with pre-existing stable condition, as determined by medical evaluation including medical history and physical examination
• Non-childbearing potential (i.e., post-menopausal for at least 1 year or surgically sterile)
• lnformed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all study procedures
• Participant must be able to receive an injection in the deltoid muscle of both arms
• Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine

Exclusion criteria Exclusion Criteria to be Checked at Screening Visit and at Visit 1 (D01) Medical conditions

• Known/suspected immunodeficiency; immunosuppressive therapy in past 6 months; long-term systemic corticosteroids
• Known systemic hypersensitivity to any study intervention components or history of life-threatening reaction to study interventions or products with the same substances
• Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
• Moderate/severe acute illness/infection (per investigator judgment)/fever (≥38.0°C [≥100.4°F]) on study intervention day. Include participant only after the condition or fever has resolved.
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
• History of serious adverse reaction to any influenza or COVID-19 vaccines per investigator's judgment
• Personal or family history of Guillain-Barré syndrome
• Prior history of myocarditis, pericarditis, or myopericarditis Prior/concomitant therapy
• Any vaccine given within 4 weeks before or within 4 weeks after study intervention
• Previous vaccination against influenza (in the previous 6 months before study intervention) with an investigational or marketed vaccine OR history of influenza infection in the previous 6 months
• Previous vaccination against COVID-19 (in the previous 6 months before study intervention) with an investigational or marketed vaccine OR history of COVID-19 infection in the previous 6 months
• Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months Other exclusion
• Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily
• Is an investigator, investigator/study center employee, or immediate family member (parent, spouse, natural/adopted child) of the investigator/employee with direct involvement in the study The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial