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NCT04657198 · ClinicalTrials.gov registry record · Phase 2
Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT04657198: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT04657198 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04657198, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.
Primary Outcome
Assessed solicited administration site AEs are erythema, pain and swelling. Any pain is defined as any pain regardless of intensity grade. Any injection site erythema/swelling is scored with a diameter larger than (\>) 20 millimeters (mm).
Interventions
- BIOLOGICAL RSVPreF3 OA investigational vaccine (GSK3844766A)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2021-10-25 |
| Phase | Phase 2 |
What the finished NCT04657198 record still lists
NCT04657198 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which RSVPreF3 OA investigational vaccine (GSK3844766A) is the first listed.
NCT04657198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04657198 about?
NCT04657198 is a clinical study titled "Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study". Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups wil...
What is the current status of trial NCT04657198?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2020-12-09. Estimated completion is 2021-10-25.
What interventions are being tested in trial NCT04657198?
The interventions under investigation include: RSVPreF3 OA investigational vaccine (GSK3844766A) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04657198?
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 NCT04657198's enrollment target sits among peer trials
126 556th of 2000 higher than 1,443 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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