Assessing Immune Response of Different COVID-19 Vaccines in Older Adults

Exclusion Criteria

• •Primary vaccination performed with different vaccine products as sole (e.g., COVID-19 Vaccine Janssen) or, 1st and 2nd vaccination doses (heterologous vaccination scheme).
• •Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.
• •Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to \>10 mg/day prednisolone.
• •Participation in other interventional trials.
• •Subjects unable to report solicited adverse events.
• •Subject with any contraindications to the vaccines in the trial at randomisation. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.
• •Use of drugs with significant interaction with the investigational product according to the SmPC or similar documents.
• •Diseases or findings that may have a significant effect on the target variables and which may therefore mask or inhibit the therapeutic effect under investigation.
• •Any current SARS-CoV-2 infection or proven in the preceding 3 months.
• •Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator.
• •Legally incapacitated persons.
• •Persons held in an institution by legal or official order.
• •Prior to study entry the subject got vaccinated with a regimen not included in the list given above.
• •Last anti-SARS-CoV-2 vaccine dose administered less than one month prior to study entry.
• •Vaccination against a disease other than COVID-19 within 2 weeks prior to study entry. Only exception: Influenza vaccination which is allowed at any time.
• •Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.
• •Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to \>10 mg/day prednisolone.
• •Subject simultaneously participates in another clinical trials or has participated in the past 30 days.
• •Subjects unable to report solicited adverse events.
• •Subject with any contraindications to the vaccines in the trial. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.