• Vaccine Name: Fluvirin
• Target Pathogen: Influenza virus
• Target Disease: Influenza (flu)
• Product Name: Influenza Virus Vaccine
• Tradename: Fluvirin
• Manufacturer: Novartis Vaccines and Diagnostics Limited
• Vaccine Ontology ID: VO_0000046
• CDC CVX code: 141, 140
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1750)
• Host Species for Licensed Use: Human
• Antigen: Influenza virus subtypes A and type B
• Preparation: FLUVIRIN is a trivalent, sub-unit influenza virus vaccine prepared from virus propagated in hens’ eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. Each of the influenza virus strains is harvested and clarified by filtration prior to inactivation. The inactivated virus is concentrated and purified by zonal centrifugation. Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine (FDA: Fluvirin).
• Storage: Recommended storage conditions are between 2º and 8ºC (36º and 46ºF). Do not freeze.
• Approved Age for Licensed Use: Persons 4 years of age and older (FDA: Fluvirin).
• Contraindication: FLUVIRIN should not be administered to anyone under 4 years of age or to anyone with a known history of systemic hypersensitivity reactions to egg proteins, or any other component of FLUVIRIN, or life-threatening reactions to previous influenza vaccinations.

Human Response

• Vaccination Protocol: Since 1991 an annual clinical study has been conducted in the
  UK in healthy adults aged 18 years or older (FDA: Fluvirin).
• Immune Response: In the adult group, for all antigens (A/H1N1, A/H3N2 and B) at least one of the following point estimate criteria was met: the proportion of subjects with seroconversion (post-vaccination titer ≥1:40 from a pre-vaccination titer <1:10) or significant increase (at least a four-fold increase from pre-vaccination titer ≥1:10) in antibody titer was greater than 40%; the geometric mean titer (GMT) increase was >2.5; the proportion of subjects with a post-vaccination hemagglutination inhibition (HI) antibody titer ≥1:40 was greater than 70% (FDA: Fluvirin).
• Immune Response Assay Type: HI antibody assay