Arexvy powder and suspension for suspension for injection Respiratory Syncytial Virus (RSV) vaccine (recombinant
Sponsors
GlaxoSmithKline Biologicals, Medical University Of Vienna, Centre hospitalier universitaire de Liege, Region Skane, Nordsjaellands Hospital
Conditions
Chronic Obstructive Pulmonary Disease (COPD)Inflammatory rheumatic diseaseRespiratory Syncytial Virus InfectionsRespiratory syncytial virusallogeneic - Hematopoietic Stem Cell Transplantation
Phase 2
A phase-2b controlled study to evaluate the humoral and cellular immune response and safety following one and two doses of an adjuvanted RSV subunit vaccine in immunocompromised patients aged 18 years and older.
RecruitingCTIS2024-513187-25-00
Start: 2024-09-10Target: 200Updated: 2025-07-14
A Phase II randomized trial of RSV vaccination in allogeneic hematopoietic stem cell transplant recipients (RSV-Allo study)
RecruitingCTIS2024-513290-53-00
Start: 2024-11-07Target: 204Updated: 2025-05-05
A Phase 2b, non-randomized, controlled, open-label, extension study to evaluate the persistence of immune response of the adjuvanted RSVPreF3 vaccine and the safety and immunogenicity following revaccination in lung and kidney transplant recipients (≥18 years of age)
RecruitingCTIS2024-519730-23-00
Start: 2025-11-10Target: 71Updated: 2025-09-19
Phase 3
A Phase 3b, open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in adults 18-49 years of age at increased risk of respiratory syncytial virus disease, compared to older adults ≥60 years of age.
CompletedCTIS2023-510190-34-00
Start: 2024-06-04End: 2025-03-13Target: 70Updated: 2025-01-31
A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above.
Active, not recruitingCTIS2024-512291-34-00
Start: 2021-02-22Target: 738Updated: 2025-10-03
Phase 4
Vaccination against respiratory syncytial virus in patients with inflammatory rheumatic diseases. The impact of anti-rheumatic treatments on the RSV immune response.
Not yet recruitingCTIS2024-518191-31-00
Target: 180Updated: 2025-07-09
COPD-2VAX: Enhancing Protection Against Respiratory Infections Through AS01-Mediated Innate Immune Activation in High-Risk Patients
Not yet recruitingCTIS2024-519163-18-00
Target: 60Updated: 2025-12-08