None of the SAEs were assessed as related to the study vaccines.The following additional adverse events have been spontaneously reported during the postmarketing use of Fluzone High-Dose, Fluzone, or Fluzone Quadrivalent and may occur in people receiving Fluzone High-Dose Quadrivalent.
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The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Fluzone High-Dose vaccine is given to people 65 years of age and older.Flublok Quadrivalent, Fluzone Quadrivalent, and Fluzone High-Dose vaccines should not be given to anyone who has had a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine (including egg or egg products for Fluzone Quadrivalent and Fluzone High-Dose vaccines) or after a previous dose of the corresponding vaccine. Discard if vaccine has been frozen.Do not use after the expiration date shown on the label.Fluzone is a registered trademark of Sanofi Pasteur Inc.Please read this information sheet before getting Fluzone High-Dose Quadrivalent vaccine. In addition, Fluzone Quadrivalent and Fluzone High-Dose vaccines should not be given to anyone who has had a severe allergic reaction after a previous dose of any influenza vaccine.Tell your health care professional if you/your child have ever experienced Guillain-Barré syndrome (severe muscle weakness) after a previous dose of influenza vaccine. (See Antibodies against one influenza virus type or subtype confer limited or no protection against another. Global surveillance of influenza viruses identifies yearly antigenic variants. Flublok Quadrivalent vaccine is given to people 18 years of age and older. FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) is a live quadrivalent vaccine for administration by intranasal spray.
Find flu vaccine near you using the vaccine finder at People with egg allergies can receive any licensed, recommended age-appropriate influenza (flu) vaccine (IIV, RIV4, or LAIV4) that is otherwise appropriate.
Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.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.Inspect Fluzone High-Dose Quadrivalent visually for particulate matter and/or discoloration prior to administration. Learn about Fluzone Quadrivalent vaccine and help protect yourself and your family against 4 different strains of flu. This summary is not intended to take the place of talking with your healthcare provider. If you notice any other problems or symptoms following vaccination, please contact your health care professional immediately.In adults, the most common side effects to Flublok Quadrivalent, Fluzone Quadrivalent, and Fluzone High-Dose vaccines include pain where the shot was given; headache and muscle aches. The objective was to demonstrate immunologic non-inferiority of Fluzone High-Dose Quadrivalent to Fluzone High-Dose, as assessed by HAI geometric mean antibody titers (GMTs) at Day 28 and seroconversion rates, to strains common to formulations of both vaccines, based on pre-specified criteria.A total of 2670 adults from 65 years of age were randomized (4:1:1) to receive one dose of either Fluzone High-Dose Quadrivalent or one of two formulations of Fluzone High-Dose (one formulation contained a B strain of the Victoria lineage [TIV-HD1] while the other contained a B strain of the Yamagata lineage [TIV-HD2]).Females accounted for 58.2% of participants in the Fluzone High-Dose Quadrivalent group and 57.4% of participants in the Fluzone High-Dose group (TIV-HD1 and TIV-HD2, pooled). The objective was to demonstrate immunologic non-inferiority of Fluzone High-Dose Quadrivalent to Fluzone High-Dose, as assessed by HAI geometric mean antibody titers (GMTs) at Day 28 and seroconversion rates, to strains common to formulations of both vaccines, based on pre-specified criteria.A total of 2670 adults from 65 years of age were randomized (4:1:1) to receive one dose of either Fluzone High-Dose Quadrivalent or one of two formulations of Fluzone High-Dose (one formulation contained a B strain of the Victoria lineage [TIV-HD1] while the other contained a B strain of the Yamagata lineage [TIV-HD2]).Females accounted for 58.2% of participants in the Fluzone High-Dose Quadrivalent group and 57.4% of participants in the Fluzone High-Dose group (TIV-HD1 and TIV-HD2, pooled).
After an episode of respiratory illness, nasopharyngeal swab samples were collected for analysis; attack rates and vaccine efficacy were calculated (see A secondary endpoint of the study was the occurrence of culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations in association with a modified CDC-defined ILI, defined as the occurrence of a temperature >99.0°F (>37.2°C) with cough or sore throat. (See Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.If Fluzone High-Dose Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be lower than expected.Vaccination with Fluzone High-Dose Quadrivalent may not protect all recipients.Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.
Fluzone is indicated for people ages 6 months and older. Vaccination with Flublok Quadrivalent, Fluzone Quadrivalent, or Fluzone High-Dose vaccine may not protect all individuals.For more information, talk to your health care professional and refer to the full Prescribing Information for Therefore, influenza vaccines are standardized to contain the hemagglutinins of influenza virus strains representing the influenza viruses likely to be circulating in the U.S. during the influenza season.Fluzone High-Dose Quadrivalent stimulates the immune system to produce antibodies that help prevent influenza disease.Fluzone High-Dose Quadrivalent has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.Study 1 (NCT03282240, see http://clinicaltrials.gov) was a randomized, active-controlled, modified double-blind trial in adults 65 years of age and older conducted in the US.
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