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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
Led by GlaxoSmithKline · Updated on 2026-04-20
750
Participants Needed
13
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants able and willing to comply with study requirements as judged by the investigator
- Written or witnessed informed consent obtained before any study procedures
- Male or female participants aged 18 to 59 years at study intervention administration
- Participants diagnosed with at least one medically stable condition such as COPD (GOLD Grade 2-4), asthma with regular treatment, cystic fibrosis, other chronic respiratory diseases, chronic heart failure (NYHA class II or higher), coronary artery disease, cardiac arrhythmia requiring treatment, diabetes mellitus types 1 or 2 with active treatment for past 6 months, chronic kidney disease (G2-G3), or moderate to severe chronic liver disease
- Female participants of non-childbearing potential or of childbearing potential who use adequate contraception from 1 month before through 1 month after intervention and have a negative pregnancy test on study day
You will not qualify if you...
- Immunosuppressive or immunodeficient conditions from disease or therapy
- History of reaction or allergy to any component of the study intervention
- Unstable chronic illness
- History of dementia or cognitive impairment
- Recurrent or uncontrolled neurological disorders or seizures (except medically controlled)
- Significant illness preventing study completion as judged by investigator
- Medical conditions making intramuscular injection unsafe
- Any other condition posing additional risk due to study participation
- Use of investigational or non-registered products within 30 days before or planned use during study
- Vaccination not foreseen by protocol within 30 days before or after intervention except certain influenza or COVID-19 vaccines
- Previous RSV vaccination including investigational RSV vaccines
- Chronic immune-modifying drug use beyond allowed limits
- Concurrent participation in another clinical study involving investigational or non-investigational vaccines or products
- History of chronic alcohol or drug abuse impacting safety reporting or compliance
- Bedridden status
- Planned move preventing study completion
- Participation of study personnel or their immediate family
- Pregnancy or lactation
- Planning pregnancy or discontinuing contraception within 1 month after intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
GSK Investigational Site
Beijing, Beijing Municipality, China, 100049
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2
GSK Investigational Site
Xiangtan, Hunan, China, 411228
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3
GSK Investigational Site
Nanjing, Jiangsu, China, 211112
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4
GSK Investigational Site
Chengdu, Sichuan, China, 611130
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5
GSK Investigational Site
Chengdu, China, 610072
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6
GSK Investigational Site
Chongqing, China, 400030
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7
GSK Investigational Site
Guangzhou, China, 510180
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8
GSK Investigational Site
Guangzhou, China, 510220
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9
GSK Investigational Site
Jiujiang, China
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10
GSK Investigational Site
Nanning, China, 530000
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11
GSK Investigational Site
Shanghai, China, 200000
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12
GSK Investigational Site
Shanghai, China, 200040
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13
GSK Investigational Site
Zhuhai, China, 519099
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Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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