This study aims to assess the efficacy of a new COVID vaccine that is to be administered in conjunction with an approved Flu vaccine.

Study Population: Healthy participants or individuals with pre-existing stable medical conditions older than 18 years of age who have received the primary vaccination series and at least one booster dose of the authorized mRNA COVID-19 vaccines (Pfizer or Moderna), ≥5 months prior to enrolment.

Clinical Visits: Screening, Day 1, 29, 57, and 181

Main Inclusion Criteria:

• Individuals are male, female, or transgender adults older than 18 years of age;
• Healthy participants or participants with pre-existing stable medical conditions.
• Individuals must agree to comply with all study visits and procedures.
• Individuals who received at least 3 doses of the authorized (Pfizer or Moderna) mRNA COVID- 19 vaccines. The last booster dose must be an authorized (Pfizer or Moderna) mRNA COVID-19 vaccine, administered at least 5 months prior to enrolment.

Main Exclusion Criteria*:

• Individuals with acute medical illness

• Individuals who have had a COVID infection in the last 5 months, or have long COVID.

• Individuals who received any influenza vaccine within 6 months prior to enrolment.

• Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenza vaccine, or excipients.

• Individuals with a history of myocarditis, pericarditis, myopericarditis, or cardiomyopathy.

• Cannot have any history of Guillain-Barre syndrome, encephalomyelitis or transverse myelitis.

*This list is not exhaustive

TO REGISTER, PLEASE FOLLOW THE LINK AT THE BOTTOM OF THIS PAGE.