NCT05921903

A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

A Phase 2b, Randomized, Controlled, Open-label Study to Evaluate the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults (>=18 Years of Age) When Administered to Lung and Renal Transplant Recipients Comparing 1 Versus 2 Doses and Compared to Healthy Controls (>=50 Years of Age) Receiving 1 Dose.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSVPreF3 OA Investigational Vaccine	0.5 mililiter dose was administered intramuscularly as 1 dose to RSV\_IC\_1 and RSV\_HA groups, and 2 doses to RSV\_IC\_2 group.

Timeline

• Start date: 2023-07-28
• Primary completion: 2024-06-25
• Completion: 2025-05-16
• First posted: 2023-06-27
• Last updated: 2025-08-08
• Results posted: 2025-07-16

Locations

46 sites across 8 countries: United States, Australia, Canada, Germany, Italy, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study