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COMPLETED
NCT05921903
PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

386

Start Date

2023-07-28

Completion Date

2025-05-16

Last Updated

2026-06-11

Healthy Volunteers

Yes

Interventions

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.

Locations (46)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Temple, Texas, United States

GSK Investigational Site

Camperdown, New South Wales, Australia

GSK Investigational Site

Birtinya, Queensland, Australia

GSK Investigational Site

Herston, Queensland, Australia

GSK Investigational Site

Adelaide, South Australia, Australia

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Giessen, Germany

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Palermo, Italy

GSK Investigational Site

Pavia, Italy

GSK Investigational Site

Siena, Italy

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Kumamoto, Japan

GSK Investigational Site

Okayama, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

A Coruña, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Córdoba, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Santander, Spain