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Fluarix Tetra Pre-filled Syringe
Fluarix Tetra is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against four strains of influenza virus.
Fluarix Tetra is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against four strains of influenza virus. Used for Seasonal influenza prevention in adults and children (age ≥6 months).
At a glance
| Generic name | Fluarix Tetra Pre-filled Syringe |
|---|---|
| Sponsor | Il-Yang Pharm. Co., Ltd. |
| Drug class | Inactivated influenza vaccine (quadrivalent) |
| Target | Influenza virus surface antigens (hemagglutinin and neuraminidase) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated (killed) influenza virus particles representing four seasonal flu strains (two A subtypes and two B lineages). Upon intramuscular injection, these antigens trigger both humoral and cellular immune responses, leading to the production of strain-specific antibodies and memory B cells that provide protection against infection with matching circulating influenza viruses.
Approved indications
- Seasonal influenza prevention in adults and children (age ≥6 months)
Common side effects
- Injection site pain, redness, or swelling
- Myalgia (muscle pain)
- Headache
- Fatigue
- Low-grade fever
Key clinical trials
- Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants (PHASE3)
- Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
- Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older (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:
- Fluarix Tetra Pre-filled Syringe CI brief — competitive landscape report
- Fluarix Tetra Pre-filled Syringe updates RSS · CI watch RSS
- Il-Yang Pharm. Co., Ltd. portfolio CI