Skip to content

A Phase 2b, randomized, controlled, open-label study to evaluate the immune response and safety of the RSVPreF3 OA investigational vaccine in adults (≥18 years of age) when administered to lung and renal transplant recipients comparing 1 versus 2 doses and compared to healthy controls (≥50 years of age) receiving 1 dose

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503951-81-00
Acronym
219900
Enrollment
130
Registered
2023-10-02
Start date
2023-11-07
Completion date
2025-07-02
Last updated
2025-04-08

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

Conditions

Respiratory Syncytial Virus Infections

Brief summary

"•RSV-A serum neutralizing titers expressed as MGI post-Dose 2 (Visit 4*) over post-Dose 1 (Visit 3*) in renal and lung SOT patients in the 2-dose group. ", •RSV-B serum neutralizing titers expressed as MGI post-Dose 2 (Visit 4*) over post-Dose 1 (Visit 3*) in renal and lung SOT patients in the 2-dose group.

Detailed description

"Secondary-Immunogenicity: •RSV-A and RSV-B serum neutralizing titers expressed as: - GMT, at pre-study and all post-study intervention visits in all participants. - Group GMT ratio RSV_HA over RSV_IC at V2-6, & IC_2 over IC_1 V4-6 - MGI at Visit 2 and 3 over Visit 1, in RSV_HA and pooled RSV_IC and at Visit 4-6 in all groups. •CMI response expressed as group GMT of the frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells at pre- and all post-study visits in a subset participants.", "Secondary-Safety •Percentage of participants reporting each solicited administration site and systemic events with onset within 7 days post-study intervention administration. •Percentage of participants reporting unsolicited AEs within 30 days post-study intervention administration (i.e., the day of vaccination and 29 subsequent days). •Percentage of participants reporting any SAEs, any pIMDs and any AESIs after study intervention administration up to study end."

Interventions

Sponsors

GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
"•RSV-A serum neutralizing titers expressed as MGI post-Dose 2 (Visit 4*) over post-Dose 1 (Visit 3*) in renal and lung SOT patients in the 2-dose group. ", •RSV-B serum neutralizing titers expressed as MGI post-Dose 2 (Visit 4*) over post-Dose 1 (Visit 3*) in renal and lung SOT patients in the 2-dose group.

Secondary

MeasureTime frame
"Secondary-Immunogenicity: •RSV-A and RSV-B serum neutralizing titers expressed as: - GMT, at pre-study and all post-study intervention visits in all participants. - Group GMT ratio RSV_HA over RSV_IC at V2-6, & IC_2 over IC_1 V4-6 - MGI at Visit 2 and 3 over Visit 1, in RSV_HA and pooled RSV_IC and at Visit 4-6 in all groups. •CMI response expressed as group GMT of the frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells at pre- and all post-study visits in a subset participants.", "Secondary-Safety •Percentage of participants reporting each solicited administration site and systemic events with onset within 7 days post-study intervention administration. •Percentage of participants reporting unsolicited AEs within 30 days post-study intervention administration (i.e., the day of vaccination and 29 subsequent days). •Percentage of participants reporting any SAEs, any pIMDs and any AESIs after study intervention administration up to study end."

Countries

Germany, Italy, Spain

Outcome results

None listed

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