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Fluzone High-dose Influenza Vaccine
Fluzone High-dose Influenza Vaccine is a Inactivated influenza vaccine Biologic drug developed by University Health Network, Toronto. It is currently in Phase 3 development for Influenza prevention in adults aged 65 years and older, Influenza prevention in immunocompromised adults.
Fluzone High-dose stimulates a stronger immune response against influenza by delivering four times the standard antigen dose per strain, enhancing antibody production and cellular immunity in older adults.
Fluzone High-dose stimulates a stronger immune response against influenza by delivering four times the standard antigen dose per strain, enhancing antibody production and cellular immunity in older adults. Used for Influenza prevention in adults aged 65 years and older, Influenza prevention in immunocompromised adults.
At a glance
| Generic name | Fluzone High-dose Influenza Vaccine |
|---|---|
| Sponsor | University Health Network, Toronto |
| Drug class | Inactivated influenza vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated influenza virus antigens at a higher concentration (60 μg per strain vs. 15 μg in standard-dose formulations). This increased antigen load triggers more robust activation of B cells and T cells, leading to higher titers of neutralizing antibodies and improved cell-mediated immunity. This enhanced immunogenicity is particularly beneficial in elderly populations whose immune systems are naturally less responsive to standard vaccines.
Approved indications
- Influenza prevention in adults aged 65 years and older
- Influenza prevention in immunocompromised adults
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)
- This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza (PHASE2)
- 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)
- A Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults (PHASE1)
- A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza (PHASE1)
- First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics (PHASE1)
- Reduced Intensity Haploidentical BMT for High Risk Solid Tumors (PHASE2)
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:
- Fluzone High-dose Influenza Vaccine CI brief — competitive landscape report
- Fluzone High-dose Influenza Vaccine updates RSS · CI watch RSS
- University Health Network, Toronto portfolio CI
Frequently asked questions about Fluzone High-dose Influenza Vaccine
What is Fluzone High-dose Influenza Vaccine?
How does Fluzone High-dose Influenza Vaccine work?
What is Fluzone High-dose Influenza Vaccine used for?
Who makes Fluzone High-dose Influenza Vaccine?
What drug class is Fluzone High-dose Influenza Vaccine in?
What development phase is Fluzone High-dose Influenza Vaccine in?
What are the side effects of Fluzone High-dose Influenza Vaccine?
Related
- Drug class: All Inactivated influenza vaccine drugs
- Manufacturer: University Health Network, Toronto — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Influenza prevention in adults aged 65 years and older
- Indication: Drugs for Influenza prevention in immunocompromised adults
- Compare: Fluzone High-dose Influenza Vaccine vs similar drugs
- Pricing: Fluzone High-dose Influenza Vaccine cost, discount & access