For infants and children who have not received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, administer a second dose of 0.25 mL or 0.5 mL IM at least 4 weeks after the initial dose. The most common side effects of Fluzone Quadrivalent Southern Hemisphere vaccine are: These are not all of the possible side effects of Fluzone Quadrivalent Southern Hemisphere vaccine. Fluzone® Quadrivalent Southern Hemisphere 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. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. Do not administer Fluzone Quadrivalent Southern Hemisphere to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11)], including egg protein, or to a previous dose of any influenza vaccine. 5 0 obj Fluzone High-Dose Quadrivalent is not recommended for persons with a history of severe allergic reaction to the vaccine or to ingredients other than eggs. The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. Fluzone Quadrivalent Southern Hemisphere and Fluzone Quadrivalent are manufactured using the same process. In the United States, Fluzone High-Dose Quadrivalent is licensed only for persons aged 65 years and older. 2) Prefilled single-dose syringe (clear syringe plunger rod), 0.5 mL, for persons 6 months of age and older. The single- dose, pre-filled syringe (0.25 mL and 0.5 mL) is formulated without thimerosal or any other preservative. Fluzone Quadrivalent Southern Hemisphere and Fluzone Quadrivalent are manufactured using the same process. The dose and schedule for Fluzone Quadrivalent Southern Hemisphere are presented in Table 1.
Antibiotics are not used in the manufacture of Fluzone Quadrivalent Southern Hemisphere. Swiftwater PA 18370 USA. The higher dose of antigen in the vaccine is intended to give older people a better immune response, and therefore, better protection against flu. See FDA-approved patient labeling (Patient Information). Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial. Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. ever had a severe allergic reaction after getting any flu vaccine. Study 1 (NCT01240746, see http://clinicaltrials.gov) was a single-blind, randomized, active- controlled multi-center safety and immunogenicity study conducted in the US. 4,5 What is the difference between Fluzone High-Dose Quadrivalent and Fluzone Quadrivalent? Influenza-like illness was defined as an illness with at least 1 respiratory symptom (cough or nasal congestion) and at least 1 constitutional symptom (fever or feverishness, chills, or body aches). You will be subject to the destination website's privacy policy when you follow the link.
This section summarizes data obtained from clinical studies with Fluzone Quadrivalent.
What are the possible side effects of Fluzone Quadrivalent Southern Hemisphere vaccine? In Study 3 (NCT00988143, see http://clinicaltrials.gov), a multi-centered randomized, open-label trial conducted in the US, adults 18 years of age and older received one dose of either Fluzone Quadrivalent or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV-2). Fluzone vaccine is a sterile suspension for intramuscular injection. Fluzone Quadrivalent Southern Hemisphere is approved for use in persons 6 months of age and older.
A study published in the New England Journal of Medicineexternal icon indicated that the high-dose vaccine was 24% more effective in preventing flu in adults 65 years and older relative to a standard-dose vaccine.
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