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NCT04886596 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 26,675
- Enrollment target
NCT04886596: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04886596 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 26,675 participants, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3364% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04886596, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 26,675 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.
Primary Outcome
First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSVPreF3 OA vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26,675 participants |
| Start Date | 2021-05-25 |
| Est. Completion | 2024-05-31 |
| Phase | Phase 3 |
What the finished NCT04886596 record still lists
NCT04886596 is an interventional study that assigns participants to a tested intervention. Its 26,675 participants enrollment target places it among the larger protocols in the corpus, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3364% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04886596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04886596 about?
NCT04886596 is a clinical study titled "Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above". This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and i...
What is the current status of trial NCT04886596?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 26,675 participants. The study started on 2021-05-25. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT04886596?
The interventions under investigation include: Placebo (BIOLOGICAL), RSVPreF3 OA vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04886596?
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 NCT04886596's enrollment target sits among peer trials
26,675 6th of 2000 higher than 1,995 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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