Clinical Trial

RSV Vaccination in Immunocompromised Patients.

Recruiting Phase 2
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Record status
This record was last updated November 27, 2024 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Respiratory syncytial Virus (RSV) causes respiratory infections worldwide and typically presents with a seasonal pattern peaking in autumn/winter in temperate climate zones. Apart from infants and elderly individuals, patients with underlying substantial respiratory, cardiovascular, endocrinological diseases and immunocompromised patients are at increased risk to develop lower respiratory tract infection (LRTI) requiring intensive care associated with increased mortality. For certain risk groups such as patients after hematologic stem cell transplantation (HSCT) in-hospital mortality may be as high as 70 %. A causally related, RSV specific treatment does not exist and treatment is therefore usually supportive and non-specific. The study is aiming to determine if immunocompromised patients benefit from two doses of a RSV subunit vaccine as opposed to one dose. The additional dose will be administered off label.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-12.
Status change: Not Yet Recruiting → Recruiting 2024-11-25
Trial Details
NCT Number NCT06597916
Lead Sponsor Medical University of Vienna
Collaborators: GlaxoSmithKline
Conditions RSV Infection
Enrollment 200 participants
Start Date 2024-09-19
Primary Completion 2025-08-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-27