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A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
NCT05921903 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.
Conditions Studied
Interventions
- BIOLOGICAL RSVPreF3 OA Investigational Vaccine
Study Locations (20)
New York
- GSK Investigational Site — New York
- GSK Investigational Site — New York
Queensland
- GSK Investigational Site — Birtinya
- GSK Investigational Site — Herston
Ontario
- GSK Investigational Site — London
- GSK Investigational Site — Toronto
Arizona
- GSK Investigational Site — Phoenix
Illinois
- GSK Investigational Site — Chicago
Kentucky
- GSK Investigational Site — Lexington
Minnesota
- GSK Investigational Site — Minneapolis
Missouri
- GSK Investigational Site — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2023-07-28 |
| Est. Completion | 2025-05-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05921903
The ClinicalTrials.gov registry entry for NCT05921903 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 386 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 1 intervention — of which RSVPreF3 OA Investigational Vaccine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05921903 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, Queensland, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05921903 about?
NCT05921903 is a clinical study titled "A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above". The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.
What is the current status of trial NCT05921903?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 386 participants. The study started on 2023-07-28. Estimated completion is 2025-05-16.
What conditions does trial NCT05921903 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05921903?
The interventions under investigation include: RSVPreF3 OA Investigational Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05921903?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05921903 being conducted?
This trial has 20 study locations across Arizona, Illinois, Kentucky, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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