
Profile
General Information
Fluzone Quadrivalent is indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses for use in persons 6 months of age and older
Flublok Quadrivalent is indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine for use in persons 18 years of age and older
Fluzone High-Dose Quadrivalent is indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for use in persons 65 years of age and older.
Fluzone Quadrivalent
The recommended dose and schedule is as follows:
Age | Vaccination Status | Dose | Schedule |
6 months through 35 months |
Not previously vaccinated with influenza vaccine or unknown vaccination history Previously vaccinated with influenza vaccine |
Two doses, either 0.25 mL or 0.5 mL*
One or two doses , either 0.25 mL or 0.5 mL* |
Administer at least 4 weeks apart If two doses, administer at least 4 weeks apart |
36 months through 8 years |
Not previously vaccinated with influenza vaccine or unknown vaccination history Previously vaccinated with influenza vaccine
|
Two 0.5 mL doses One or two 0.5 mL doses |
Administer at least 4 weeks apart If two doses, administer at least 4 weeks apart |
9 years and older | One 0.5 mL dose |
Flublok Quadrivalent:
Administer Flublok Quadrivalent as a single 0.5 mL dose
Fluzone High-Dose Quadrivalent
Should be administered as a single 0.7 mL injection by the intramuscular route in adults 65 years of age and older..
Side Effects
Adverse effects may include, but are not limited to, the following:
- injection-site reactions
- pain
- erythema
- swelling
- myalgia
- malaise
- headache
- fatigue
Clinical Trial Results
Fluzone High-Dose Quadrivalent
FDA approval was based on data from a Phase 3 immunogenicity and safety study, in which Fluzone High-Dose Quadrivalent achieved the primary endpoint of non-inferior immunogenicity compared to two trivalent formulations of Fluzone High-Dose, each containing one of the two influenza B strains recommended for inclusion in the vaccine for the 2017-2018 influenza season. In a secondary endpoint of the trial, each B strain in Fluzone High-Dose Quadrivalent induced a superior immune response compared to the trivalent formulation not containing the corresponding B strain.
Fluzone Quadrivalent
Flublok Quadrivalent
Approval Date: 2002-09-01
Company Name: Sanofi Pasteur