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GSK Biologicals' Fluarix™
Fluarix is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against seasonal influenza virus strains.
Fluarix is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against seasonal influenza virus strains. Used for Seasonal influenza prevention in adults and children.
At a glance
| Generic name | GSK Biologicals' Fluarix™ |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Inactivated influenza vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Fluarix contains inactivated (killed) influenza virus antigens from three or four seasonal flu strains. When administered, it triggers the adaptive immune response, prompting B cells to produce neutralizing antibodies and T cells to develop cellular immunity against the included influenza strains. This immune memory protects vaccinated individuals from infection or reduces disease severity if exposed to matching circulating flu viruses.
Approved indications
- Seasonal influenza prevention in adults and children
Common side effects
- Injection site soreness or erythema
- Myalgia
- Headache
- Fatigue
- Low-grade fever
Key clinical trials
- Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age (PHASE3)
- Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children (PHASE2)
- Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older (PHASE4)
- Revaccination With Influenza Vaccine GSK1247446A (PHASE2)
- Study to Evaluate an Influenza Vaccine Candidate (PHASE2)
- Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children (PHASE2)
- Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age. (PHASE4)
- An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children (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:
- GSK Biologicals' Fluarix™ CI brief — competitive landscape report
- GSK Biologicals' Fluarix™ updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI