• Vaccine Name: Agriflu
• Target Pathogen: Influenza virus
• Target Disease: Influenza (flu)
• Product Name: Influenza Virus Vaccine
• Tradename: Agriflu
• Manufacturer: Novartis Vaccines and Diagnostics Inc.
• Vaccine Ontology ID: VO_0001126
• CDC CVX code: 140
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA
• Host Species for Licensed Use: Human
• Allergen: Eggs, kanomycin, neomycin
• Preparation: The trivalent inactivated vaccine consists of virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with an influenza virus suspension containing kanamycin and neomycin sulphate, which is then filtered and inactivated by treatment with formaldehyde. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of cetyltrimethylammonium bromide (CTAB), a process which removes most of the internal proteins. The CTAB is removed from the vaccine preparation by subsequent purification steps (FDA: Agriflu).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: 2-8°C
• Approved Age for Licensed Use: 18 years and older
• Description: AGRIFLU® is an inactivated vaccine indicated for active immunization for the prevention of disease caused by influenza virus subtypes A and type B contained in the vaccine (FDA: Agriflu).

Human Response

• Vaccination Protocol: Study in Argentina of 632 adults ranging from ages 18-64, subjects were given Agriflu or comparator vaccine. 424 subjects received Agriflu and 219 received the comparator vaccine (FDA: Agriflu).
• Immune Response: Serum HI antibody responses 21 days after vaccination with AGRIFLU met the pre-specified co-primary endpoint criteria for all three viral strains included in the vaccine.
• Immune Response Assay Type: HI antibody assay

Human Response

• Vaccination Protocol: Study done in the Dominican Republic of 1507 adults ages 18-49. Subjects were randomly assigned at a 2:2:2:1 ratio to receive either one of three consecutive AGRIFLU lots or the US-licensed influenza vaccine used for comparison (FDA: Agriflu).
• Immune Response: Serum HI antibody responses 21 days after vaccination with AGRIFLU met the pre-specified co-primary endpoint criteria for all three viral strains included in the vaccine.
• Immune Response Assay Type: HI antibody assay