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Fluzone High-Dose vaccine
Fluzone High-Dose vaccine stimulates a stronger immune response against influenza virus strains by delivering four times the standard antigen dose per strain.
Fluzone High-Dose vaccine stimulates a stronger immune response against influenza virus strains by delivering four times the standard antigen dose per strain. Used for Prevention of seasonal influenza in adults aged 65 years and older.
At a glance
| Generic name | Fluzone High-Dose vaccine |
|---|---|
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | inactivated influenza vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains inactivated influenza virus antigens at a higher concentration (60 micrograms per strain versus 15 micrograms in standard-dose formulations) to enhance immunogenicity in older adults whose immune systems are less responsive. This increased antigen load triggers greater production of protective antibodies and T-cell responses, providing improved protection against seasonal influenza infection and complications.
Approved indications
- Prevention of seasonal influenza in adults aged 65 years and older
Common side effects
- Injection site soreness
- Myalgia (muscle aches)
- Fatigue
- Headache
- Low-grade 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)
- 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)
- Reduced Intensity Haploidentical BMT for High Risk Solid Tumors (PHASE2)
- A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer (PHASE1)
- A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults (PHASE1)
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 vaccine CI brief — competitive landscape report
- Fluzone High-Dose vaccine updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI