RecruitingPhase 3NCT07220109

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Phase 3, Randomized, Controlled, Observer Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Chinese Adults 18-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease


Sponsor

GlaxoSmithKline

Enrollment

750 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.


Eligibility

Min Age: 18 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Placebo and a biological treatment called RSVPreF3 OA vaccine for people with respiratory syncytial virus infections. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years to 59 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRSVPreF3 OA vaccine

1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

BIOLOGICALPlacebo

1 dose of saline solution administered intramuscularly in the deltoid region of the non-dominant arm.


Locations(15)

GSK Investigational Site

Beijing, Beijing Municipality, China

GSK Investigational Site

Xiangtan, Hunan, China

GSK Investigational Site

Nanjing, Jiangsu, China

GSK Investigational Site

Chengdu, Sichuan, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Chongqing, China

GSK Investigational Site

Chongqing, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Jiujiang, China

GSK Investigational Site

Kunming, China

GSK Investigational Site

Nanning, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Zhuhai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07220109


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