• Vaccine Name: Fluzone
• Target Pathogen: Influenza virus
• Target Disease: Influenza (flu)
• Product Name: Influenza Virus Vaccine
• Tradename: Fluzone
• Manufacturer: Sanofi Pasteur, Inc.
• Vaccine Ontology ID: VO_0000047
• CDC CVX code: 141, 140
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1725)
• Host Species for Licensed Use: Human
• Antigen: Influenza virus subtypes A and type B
• Preservative: None
• Allergen: Eggs
• Preparation: Fluzone vaccine (Influenza Virus Vaccine) is prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene glycol p-isooctylphenyl ether, (Triton X-100) producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.
  Ref: http://www.fda.gov/cber/label/fluzoneLB.pdf
• Immunization Route: Intramuscular injection (i.m.)
• Virulence: Most adverse events in clinical trials were mild and self-limited.
• Storage: Store between 2º and 8ºC (36º and 46ºF). Do not freeze.
• Approved Age for Licensed Use: Ages 6 months and older. (FDA: Fluzone)
• Contraindication: FLUZONE should not be administered to anyone with known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis (FDA: Fluzone).
• Description: Fluzone is a vaccine indicated for active immunization in persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

Human Response

• Vaccination Protocol: A placebo-controlled study of adults ranging in ages 19 to 59 and on a geriatric population ranging in ages 61 to 86 years of age was carried out in the United States. An administration of a single-dose of 1999-2000 formulation of the FLUZONE vaccine was given to all test subjects (FDA: Fluzone).
• Immune Response: In the adult and geriatric popolution, serum hemagglutination-inhibiting (HI) antibody responses to FLUZONE were significantly higher after immunization for all three virus strains (HiNi, H3N2, and B) (FDA: Fluzone).
• Immune Response Assay Type: HI antibody assay
• Side Effects: Placebo-controlled trials demonstrate that among older persons and healthy young adults, administration of FLUZONE is not associated with higher rates of systemic symptoms (i.e fever, malaise, myalgia, and headache) when compared with placebo injections (FDA: Fluzone). The most frequent side effects of FLUZONE are soreness at the injection site, local pain and swelling. These symptoms were recorded as lasting less than two days after injection of the vaccine. Other symptoms include fever, malaise, myalgia, and other systemic symptoms most likely prompted by the subject not having prior exposure to the vaccine (FDA: Fluzone).

Human Response

• Vaccination Protocol: A clinical study was conducted in healthy children ranging in ages 6 to 36 months of age using two doses one month apart of the 2003-2004 formulation of FLUZONE vaccine.
• Immune Response: The FLUZONE vaccine administered in the children had similar proportions of immune responses as those that were in adults.
• Side Effects: Side effects of the FLUZONE injection in these children included: local reactions such a pain at injection site and swelling. Most of the local and systemic reactions were mild and were similiar in proportion to reactions observed in adults. The only side effect that required intervention was analgesics.