• Vaccine Name: Fluzone High-Dose
• Target Pathogen: Influenza virus
• Target Disease: Influenza (flu)
• Product Name: Influenza Virus Vaccine
• Tradename: Fluzone High-Dose
• Manufacturer: Sanofi Pasteur
• Vaccine Ontology ID: VO_0001127
• CDC CVX code: 135
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA
• Host Species for Licensed Use: Human
• Preservative: Thimerosol
• Allergen: Eggs
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Refrigerated at 2° to 8°C (35° to 46°F). Do not freeze.
• Approved Age for Licensed Use: 65 years and older
• Contraindication: Egg allergies
• Description: Fluzone High-Dose is an inactivated influenza virus vaccine indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine (FDA: Fluzone).

Human Response

• Vaccination Protocol: A study of 2 doses one month apart of Fluzone (2003-2004) in 31 healthy children 6-36 months of age (FDA: Fluzone).
• Immune Response: In a study of 2 doses one month apart of Fluzone (2003-2004) in 31 healthy children 6-36 months of age, 77%, 77%, and 48% achieved post vaccination HI titers of 1:40 or greater for the A/H1, A/H3, and B strains, respectively (FDA: Fluzone).
• Immune Response Assay Type: HI antibody assay

Human Response

• Vaccination Protocol: A total of 3,876 individuals 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone in a phase 3, multi-center, randomized, active-controlled, double blind trial conducted in the US (FDA: Fluzone).
• Immune Response: Statistically superior HI titers after vaccination with Fluzone High-Dose compared to standard dose Fluzone were demonstrated for two of the three influenza strains (FDA: Fluzone).

Human Response

• Vaccination Protocol: A total of 3,876 individuals 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone in a phase 3, multi-center, randomized, active-controlled, double blind trial conducted in the US (FDA: Fluzone).
• Immune Response: Statistically superior HI titers after vaccination with Fluzone High-Dose compared to standard dose Fluzone were demonstrated for two of the three influenza strains (FDA: Fluzone).