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NCT06389487 · ClinicalTrials.gov registry record · Phase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,459
- Enrollment target
NCT06389487: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT06389487 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,459 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06389487, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,459 participants
- Enrollment target
Study Summary
The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.
Primary Outcome
RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)
Interventions
- BIOLOGICAL RSVPreF3 OA investigational vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,459 participants |
| Start Date | 2024-04-29 |
| Est. Completion | 2025-03-18 |
| Phase | Phase 3 |
What the finished NCT06389487 record still lists
NCT06389487 is an interventional study that assigns participants to a tested intervention. Its 1,459 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% higher).
The record links to 0 conditions, and to 1 intervention - of which RSVPreF3 OA investigational vaccine is the first listed.
NCT06389487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06389487 about?
NCT06389487 is a clinical study titled "A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above". The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.
What is the current status of trial NCT06389487?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,459 participants. The study started on 2024-04-29. Estimated completion is 2025-03-18.
What interventions are being tested in trial NCT06389487?
The interventions under investigation include: RSVPreF3 OA investigational vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06389487?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06389487's enrollment target sits among peer trials
1,459 164th of 2000 higher than 1,837 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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