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A Phase 3 Randomized, Controlled, Observer-Blind Study to Evaluate Immunogenicity, Safety, and Reactogenicity of a Single Dose of GSK's RSVPreF3 OA Vaccine in Chinese Adults 18-59 Years at Increased Risk of RSV Disease
Led by GlaxoSmithKline · Updated on 2026-05-27
750
Participants Needed
15
Research Sites
24 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the immune response and safety of the RSVPreF3 OA investigational vaccine in Chinese adults aged 18 to 59 years who are at increased risk of respiratory syncytial virus (RSV) disease. The study compares the immune response generated in this age group to that observed in older adults aged 60 years and above from a previous study. This Phase 3 trial aims to assess both the immune response and the safety profile of a single dose of the vaccine. Participants at increased risk of RSV disease will be randomly assigned to receive either a single dose of the RSVPreF3 OA vaccine or a placebo, both administered intramuscularly in the deltoid region of the non-dominant arm on Day 1. The study is observer-blind and controlled, ensuring unbiased assessment of outcomes. The trial will monitor participants for immune responses and any side effects following vaccination. During the study, researchers will measure RSV-A and RSV-B neutralizing antibody levels at one month and six months after vaccination. They will also track occurrences and duration of RSV-associated respiratory illnesses, symptom severity, and any adverse events up to six months post-vaccination. Participants will be closely monitored for safety and reactogenicity, including solicited local and systemic events during the first week and any serious adverse events throughout the study period. The total participation duration is six months following the vaccine or placebo administration.
CONDITIONS
Brief 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 must be able and willing to comply with study requirements.
- Must provide written or witnessed informed consent.
- Male or female aged 18 to 59 years at the time of vaccine administration.
- Diagnosed with at least one medically stable condition increasing RSV risk, such as chronic cardiopulmonary disease, chronic heart failure (NYHA class II or higher), coronary artery disease, cardiac arrhythmia, diabetes mellitus (type 1 or 2) with active treatment, chronic kidney disease (stages 2-3), or moderate to severe chronic liver disease.
- Female participants of non-childbearing potential or those of childbearing potential must practice adequate contraception and have a negative pregnancy test prior to vaccination.
- Childbearing potential females must agree to continue contraception for at least one month after vaccination.
You will not qualify if you...
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
- History of reaction or hypersensitivity to any vaccine component.
- Unstable chronic illness.
- History of dementia or moderate to severe cognitive impairment.
- Recurrent or uncontrolled neurological disorders or seizures.
- Significant illness expected to prevent study completion.
- Any condition making intramuscular injection unsafe.
- Use of investigational or non-registered products within 30 days before vaccination or planned use during the study.
- Vaccination with any RSV vaccine before.
- Chronic use of immune-modifying drugs or planned use during the study.
- Concurrent participation in other clinical studies involving investigational vaccines or products.
- History of chronic alcohol or drug abuse impacting study compliance.
- Bedridden status.
- Planned relocation preventing study completion.
- Participation of study personnel or their immediate family.
- Pregnant or lactating women.
- Women planning pregnancy or stopping contraception within one month after vaccination.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of either the investigational RSVPreF3 OA vaccine or placebo by intramuscular injection in the deltoid region of the non-dominant arm.
1 vaccination visit (in-person)
Duration - 6 months
Participants are monitored for safety, immune response, and any respiratory illness for up to 6 months after vaccination.
Multiple visits including assessments at Day 31, Month 6, and periodic safety and symptom monitoring visits
Trial Site Locations
Total: 15 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
Chongqing, China, 401336
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8
GSK Investigational Site
Guangzhou, China, 510180
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9
GSK Investigational Site
Guangzhou, China, 510220
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10
GSK Investigational Site
Jiujiang, China
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11
GSK Investigational Site
Kunming, China, 650032
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12
GSK Investigational Site
Nanning, China, 530000
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13
GSK Investigational Site
Shanghai, China, 200000
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14
GSK Investigational Site
Shanghai, China, 200040
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15
GSK Investigational Site
Zhuhai, China, 519099
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Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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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