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NCT05921903 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 386
- Enrollment target
- 20
- Study locations
NCT05921903: Completed Phase 2 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
NCT05921903 is a Phase 2 study of Respiratory Syncytial Virus Infections that has completed, run by GlaxoSmithKline. The registered enrollment target is 386 participants, below the 1,073-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05921903, a Phase 2 study of Respiratory Syncytial Virus Infections, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 386 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).
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 |
What the finished NCT05921903 record still lists
NCT05921903 is an interventional study that assigns participants to a tested intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap, below the 1,073-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (64% lower).
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.
NCT05921903 names 20 study sites across 17 states, led by New York, Queensland, Ontario.
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.
What interventions are being tested in trial NCT05921903?
The interventions under investigation include: RSVPreF3 OA Investigational Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05921903?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Respiratory Syncytial Virus Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05921903's enrollment target sits among peer trials
386 9th of 21 higher than 13 of 21 other Respiratory Syncytial Virus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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