NCT06389487

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 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults >=60 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,459 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Timeline

• Start date: 2024-04-29
• Primary completion: 2024-07-29
• Completion: 2025-03-18
• First posted: 2024-04-29
• Last updated: 2025-09-25
• Results posted: 2025-09-25

Locations

52 sites across 6 countries: United States, Australia, Canada, Germany, Japan, South Africa

Regulatory

• FDA-regulated drug study