Last reviewed · How we verify
RSVPreF3 vaccine
The RSVPreF3 vaccine works by stimulating the body to produce a protective immune response against the respiratory syncytial virus (RSV).
The RSVPreF3 vaccine works by stimulating the body to produce a protective immune response against the respiratory syncytial virus (RSV). Used for Prevention of severe lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants and young children.
At a glance
| Generic name | RSVPreF3 vaccine |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This is achieved through the administration of a vaccine that contains a weakened form of the RSV virus, which triggers the body's immune system to produce antibodies and immune cells that can recognize and fight the virus. The vaccine is designed to provide long-term protection against severe RSV disease.
Approved indications
- Prevention of severe lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants and young children
Common side effects
- Injection site pain
- Fever
- Vomiting
Key clinical trials
- Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above (PHASE3)
- A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control (PHASE3)
- 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 (PHASE3)
- An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study (PHASE3)
- A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant (PHASE2)
- A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older (PHASE3)
- A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above (PHASE3)
- A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- RSVPreF3 vaccine CI brief — competitive landscape report
- RSVPreF3 vaccine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI