Adult volunteers (M/F) aged ≥75 years who are healthy or have stable disease
Conditions
Brief summary
Anti-S IgG levels in serum 28 days after vaccination, expressed in geometric mean concentrations (GMC)
Detailed description
SARS-CoV-2 neutralising antibody titres in serum 28 days after vaccination, expressed in geometric mean titres (GMT), The percentage of participants reporting: - Solicited adverse events (AEs) (local reactions, reaction of regional lymph nodes, and systemic reactions up to 14 days following vaccination), unsolicited AEs up to 28 days following vaccination, serious AEs (SAEs) up to 28 days following vaccination and use of antipyretics and analgesics up to 14 days following vaccination.
Interventions
DRUGComirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
Sponsors
Stichting Radboud University Medical Center
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-S IgG levels in serum 28 days after vaccination, expressed in geometric mean concentrations (GMC) | — |
Secondary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 neutralising antibody titres in serum 28 days after vaccination, expressed in geometric mean titres (GMT), The percentage of participants reporting: - Solicited adverse events (AEs) (local reactions, reaction of regional lymph nodes, and systemic reactions up to 14 days following vaccination), unsolicited AEs up to 28 days following vaccination, serious AEs (SAEs) up to 28 days following vaccination and use of antipyretics and analgesics up to 14 days following vaccination. | — |
Countries
Netherlands
Outcome results
None listed