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..

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