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NCT06374394 · ClinicalTrials.gov registry record · Phase 3
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above
A Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 841
- Enrollment target
- 20
- Study locations
NCT06374394 is a Phase 3 study of Respiratory Syncytial Virus Infections that has completed, run by GlaxoSmithKline. The registered enrollment target is 841 participants, below the 1,051-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT06374394, a Phase 3 study of Respiratory Syncytial Virus Infections, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 841 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is assessing the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.
Conditions Studied
Interventions
- BIOLOGICAL RSVPreF3 OA investigational vaccine
- BIOLOGICAL COVID-19 mRNA vaccine
Study Locations (20)
Other
- GSK Investigational Site - Antwerp
- GSK Investigational Site - Edegem
- GSK Investigational Site - Ghent
- GSK Investigational Site - Kluisbergen
- GSK Investigational Site - Mechelen
- GSK Investigational Site - Breda
- GSK Investigational Site - Enschede
- GSK Investigational Site - Utrecht
- GSK Investigational Site - Zutphen
- GSK Investigational Site - A Coruña
- GSK Investigational Site - Barcelona
- GSK Investigational Site - Barcelona
Florida
- GSK Investigational Site - Coral Gables
Georgia
- GSK Investigational Site - Savannah
Indiana
- GSK Investigational Site - Evansville
Nebraska
- GSK Investigational Site - Omaha
New York
- GSK Investigational Site - Rochester
North Carolina
- GSK Investigational Site - Winston-Salem
South Carolina
- GSK Investigational Site - North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 841 participants |
| Start Date | 2024-04-29 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06374394
The ClinicalTrials.gov registry entry for NCT06374394 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 841 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,051-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (20% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 2 interventions - of which RSVPreF3 OA investigational vaccine is the first listed.
NCT06374394 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT06374394 about?
NCT06374394 is a clinical study titled "A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above". This study is assessing the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and a...
What is the current status of trial NCT06374394?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 841 participants. The study started on 2024-04-29. Estimated completion is 2025-03-31.
What conditions does trial NCT06374394 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT06374394?
The interventions under investigation include: RSVPreF3 OA investigational vaccine (BIOLOGICAL), COVID-19 mRNA vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06374394?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06374394 being conducted?
This trial has 20 study locations across Florida, Georgia, Indiana, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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