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FLU HD vaccine
FLU HD vaccine is a Inactivated influenza vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of influenza in adults aged 65 years and older, Prevention of influenza in adults aged 18 years and older (Phase 3 evaluation).
FLU HD vaccine stimulates a stronger immune response against influenza virus by delivering a higher antigen dose compared to standard-dose flu vaccines.
The FLU HD vaccine is a high-dose, quadrivalent, inactivated influenza vaccine that induces an immune response. It is used to prevent influenza in individuals, with its mechanism of action classified as a biological vaccine.
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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 | FLU HD vaccine |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Inactivated influenza vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
FLU HD is an inactivated influenza vaccine formulated with four times the standard antigen content per strain, designed to elicit a more robust humoral and cellular immune response, particularly in older adults who may have diminished immune responsiveness. The higher antigen dose aims to improve vaccine efficacy and reduce influenza-related morbidity and mortality in elderly populations.
Approved indications
- Prevention of influenza in adults aged 65 years and older
- Prevention of influenza in adults aged 18 years and older (Phase 3 evaluation)
Common side effects
- Injection site soreness
- Myalgia
- Headache
- Fatigue
- Fever
Key clinical trials
- Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) (PHASE1)
- A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine (PHASE1)
- Influenza Vaccination Strategy for Patients With Hematologic Malignancy (PHASE3)
- Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine (PHASE1, PHASE2)
- A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults (PHASE2)
- High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients (PHASE2)
- Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age (PHASE3)
- Open-Label Influenza Vaccine Evaluation (NA)
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:
- FLU HD vaccine CI brief — competitive landscape report
- FLU HD vaccine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about FLU HD vaccine
What is FLU HD vaccine?
How does FLU HD vaccine work?
What is FLU HD vaccine used for?
Who makes FLU HD vaccine?
What drug class is FLU HD vaccine in?
What development phase is FLU HD vaccine in?
What are the side effects of FLU HD vaccine?
Related
- Drug class: All Inactivated influenza vaccine drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of influenza in adults aged 65 years and older
- Indication: Drugs for Prevention of influenza in adults aged 18 years and older (Phase 3 evaluation)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing