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Fluarix™/Influsplit SSW®
Fluarix™/Influsplit SSW® is a Inactivated influenza vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Seasonal influenza prevention in adults and children.
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.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Fluarix™/Influsplit SSW® |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Inactivated influenza vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated (killed) influenza virus antigens from three or four seasonal strains, which trigger both humoral and cellular immune responses. Upon vaccination, the body produces specific antibodies and T-cell responses that provide protection against infection by matching circulating influenza viruses during the flu season.
Approved indications
- Seasonal influenza prevention in adults and children
Common side effects
- Injection site soreness, redness, or swelling
- Myalgia (muscle aches)
- Headache
- Fatigue
- Low-grade fever
Key clinical trials
- A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults (PHASE3)
- A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults (PHASE3)
- Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old (PHASE4)
- A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in Adults (PHASE3)
- Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above (PHASE3)
- Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM (PHASE3)
- Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above (PHASE3)
- Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04 (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™/Influsplit SSW® CI brief — competitive landscape report
- Fluarix™/Influsplit SSW® updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Fluarix™/Influsplit SSW®
What is Fluarix™/Influsplit SSW®?
How does Fluarix™/Influsplit SSW® work?
What is Fluarix™/Influsplit SSW® used for?
Who makes Fluarix™/Influsplit SSW®?
What drug class is Fluarix™/Influsplit SSW® in?
What development phase is Fluarix™/Influsplit SSW® in?
What are the side effects of Fluarix™/Influsplit SSW®?
Related
- Drug class: All Inactivated influenza vaccine drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Seasonal influenza prevention in adults and children
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing