Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine

Exclusion Criteria

• •Participant with an acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator
• •Participant with a medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• •Participant with history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention
• •Immunocompromised individuals defined as those with primary and secondary immune deficiencies and those receiving chemotherapy or immunosuppressant drugs other than steroids and glucocorticoids (maximum 30mg/day of prednisone, or equivalent, by any administration route for a maximum of 30 consecutive days), within 90 days prior to vaccination
• •Participant with a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
• •Have receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months
• •Participation in other studies involving study intervention if last dose is within 28 days prior to screening and/or it is planned to receive during study participation
• •Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening
• •Received any COVID-19 vaccines other than EU-approved mRNA vaccines
• •Received any Omicron XBB adapted vaccine before Day 0
• •COVID-19 infection diagnosed in the previous 6 months before Day 0. History of COVID-19 infections is allowed
• •History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.