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Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Fluzone Quadrivalent is approved for use in persons 6 months of age and older.
Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation.
Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color.
Antibiotics are not used in the manufacture of Fluzone Quadrivalent.
The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex.
Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2014-2015 influenza season: A/California/07/2009 X-179A (H1N1), A/Texas/50/2012 X-223A (H3N2), B/Massachusetts/02/2012 (B Yamagata lineage), and B/Brisbane/60/2008 (B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 6. The single-dose, pre-filled syringe (0.25 mL and 0.5 mL) and the single-dose vial (0.5 mL) are manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.
| Ingredient | Quantity (per dose) |
|
|---|---|---|
| Fluzone Quadrivalent 0.25 mL Dose |
Fluzone Quadrivalent 0.5 mL Dose |
|
| “-” Indicates information is not applicable | ||
|
||
| Active Substance: Split influenza virus, inactivated strains*: | 30 mcg HA total | 60 mcg HA total |
| A (H1N1) | 7.5 mcg HA | 15 mcg HA |
| A (H3N2) | 7.5 mcg HA | 15 mcg HA |
| B/(Victoria lineage) | 7.5 mcg HA | 15 mcg HA |
| B/(Yamagata lineage) | 7.5 mcg HA | 15 mcg HA |
| Other: | ||
| Sodium phosphate-buffered isotonic sodium chloride solution | QS† to appropriate volume | QS† to appropriate volume |
| Formaldehyde | ≤50 mcg | ≤100 mcg |
| Octylphenol ethoxylate | ≤125 mcg | ≤250 mcg |
| Preservative | ||
| Single-dose presentations | – | – |
| Multi-dose presentation (thimerosal) | 12.5 mcg mercury | 25 mcg mercury |