Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 24 May 2017

Indication(s)

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. (1)

Fluzone Quadrivalent is approved for use in persons 6 months of age and older. (1)

Full Prescribing information

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Advisory information

contraindications

Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine. (4)

Special warnings and precautions

• If Guillain-Barré syndrome (GBS) has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent should be based on careful consideration of the potential benefits and risks. (5.1)

Adverse reactions

• In children 6 months through 35 months of age, the most common (≥10%) injection-site reactions were pain (57%) or tenderness (54%), erythema (37%), and swelling (22%); the most common solicited systemic adverse reactions were irritability (54%), abnormal crying (41%), malaise (38%), drowsiness (38%), appetite loss (32%), myalgia (27%), vomiting (15%), and fever (14%). (6.1)
• In children 3 years through 8 years of age, the most common (≥10%) injection-site reactions were pain (67%), erythema (34%), and swelling (25%); the most common solicited systemic adverse reactions were myalgia (39%), malaise (32%), and headache (23%). (6.1)
• In adults 18 years and older, the most common (≥10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). (6.1)
• In adults 65 years of age and older, the most common (≥10%) injection-site reaction was pain (33%); the most common solicited systemic adverse reactions were myalgia (18%), headache (13%), and malaise (11%). (6.1)

Usage information

Dosing and administration
• For intramuscular use only (2)
Age Dose Schedule
6 months through 35
months
One or two dosesa, 0.25 mL each If 2 doses, administer at least 4 weeks apart
36 months through
8 years
One or two dosesa, 0.5 mL each If 2 doses, administer at least 4 weeks apart
9 years and older One dose, 0.5 mL -
a1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines

"-" Indicates information is not applicable

Use in special populations
• Safety and effectiveness of Fluzone Quadrivalent have not been established in pregnant women or children less than 6 months of age. (8.4)
• Pregnancy: Pregnancy registry available. Call Sanofi Pasteur Inc. at 1-800-822-2463.
• Antibody responses to Fluzone Quadrivalent are lower in persons ≥65 years of age than in younger adults. (8.5)

More information

Category Value
Authorisation number BLA103914
Orphan designation No
Product NDC 49281-416; 49281-516; 49281-625
Date First Approved 01-07-2016
Marketing authorisation holder Sanofi Pasteur Inc.