Skip to content

A Phase III, open-label, randomized, controlled, multi-country study to evaluate the immune response, safety and reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with 20-valent pneumococcal conjugate vaccine (PCV20) in adults aged 60 years and older.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501988-40-00
Acronym
219276
Enrollment
407
Registered
2023-07-17
Start date
2023-08-17
Completion date
2024-05-07
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RSV-associated (subtypes A and B) disease in adults aged 60 years of age and older.

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

GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026