RSV-associated (subtypes A and B) disease in adults aged 60 years of age and older.
Conditions
Brief summary
• Opsonophagocytic (OP) antibody (Ab) titers for each of the pneumococcal vaccine serotype (ST) expressed as between groups geometric mean titer (GMT) ratio, 1 month after the PCV20 dose., • RSV-A neutralizing Ab titers expressed as between groups GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine dose., • RSV-B neutralizing Ab titers expressed as between groups GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine dose.
Detailed description
• RSV-A neutralizing Ab titers expressed as mean geometric increase (MGI) over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose., • RSV-B neutralizing Ab titers expressed as MGI over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose., • Percentage of participants reporting each solicited event with onset within 7 days after vaccine administration (i.e., the day of vaccination and 6 subsequent days), • Percentage of participants reporting unsolicited AE within 30 days after vaccine administration (i.e., the day of vaccination and 29 subsequent days), • Percentage of participants reporting SAEs after vaccine administration (Day 1) up to EoS (6 months after last vaccination)., • Percentage of participants reporting pIMDs after vaccine administration (Day 1) up to EoS (6 months after last vaccination).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Opsonophagocytic (OP) antibody (Ab) titers for each of the pneumococcal vaccine serotype (ST) expressed as between groups geometric mean titer (GMT) ratio, 1 month after the PCV20 dose., • RSV-A neutralizing Ab titers expressed as between groups GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine dose., • RSV-B neutralizing Ab titers expressed as between groups GMT ratio, 1 month after the RSVPreF3 OA investigational vaccine dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| • RSV-A neutralizing Ab titers expressed as mean geometric increase (MGI) over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose., • RSV-B neutralizing Ab titers expressed as MGI over baseline at 1 month after the RSVPreF3 OA investigational vaccine dose., • Percentage of participants reporting each solicited event with onset within 7 days after vaccine administration (i.e., the day of vaccination and 6 subsequent days), • Percentage of participants reporting unsolicited AE within 30 days after vaccine administration (i.e., the day of vaccination and 29 subsequent days), • Percentage of participants reporting SAEs after vaccine administration (Day 1) up to EoS (6 months after last vaccination)., • Percentage of participants reporting pIMDs after vaccine administration (Day 1) up to EoS (6 months after last vaccination). | — |
Countries
Belgium, Poland, Spain