NCT06374394

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, Open-label, Randomized, Controlled Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-Administered With a COVID-19 mRNA Vaccine (Omicron XBB.1.5) in Adults Aged 50 Years and Above

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 841 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSVPreF3 OA investigational vaccine	1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1 to participants in the Co-ad Group and on Day 31 to participants in the Control Group.
BIOLOGICAL	COVID-19 mRNA vaccine	1 dose of COVID-19 mRNA vaccine is administered intramuscularly on Day 1 to participants in the Co-ad and Control Groups.

Timeline

• Start date: 2024-04-29
• Primary completion: 2024-11-01
• Completion: 2025-03-31
• First posted: 2024-04-18
• Last updated: 2025-12-26
• Results posted: 2025-12-26

Locations

24 sites across 4 countries: United States, Belgium, Netherlands, Spain

Regulatory

• FDA-regulated drug study