• Vaccine Name: Influenza Virus Vaccine H5N1 by Sanofi Pasteur Inc
• Target Pathogen: Influenza virus
• Target Disease: Influenza (flu)
• Product Name: Influenza Virus Vaccine, H5N1
• Tradename: Influenza Virus Vaccine, H5N1
• Manufacturer: Sanofi Pasteur Inc.
• Vaccine Ontology ID: VO_0000065
• Type: Inactivated or "killed" monovalent vaccine
• Status: Licensed
• Location Licensed: USA (License #1725)
• Host Species for Licensed Use: Human
• Antigen: inactivated monovalent influenza virus H5N1
• Preparation: A sterile suspension of H5N1 is prepared from an influenza virus propagated in embryonated chicken eggs which are harvested and inactivated with formaldehyde. The influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is "split" and then further purified and suspended in sodium phosphate-buffered isotonic sodium chloride solution (FDA: Sanofi Pasteur H5N1).
• Immunization Route: Intramuscular injection (i.m.)
• Virulence: There were no adverse effects recorded in clinical trials of this vaccine.
• Storage: The H5N1 multi-dose vial should be stored at a temperature of 35 to 46 degrees Fahrenheit. DO NOT FREEZE. The vaccine should be shaken vigorously each time before withdrawning of a dose.
• Approved Age for Licensed Use: Ages 18-64
• Contraindication: H5N1 should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins, or to any component of H5N1 or who has had a life-threatening reaction to previous administration of any influenza vaccine.
• Description: Influenza Virus Vaccine, H5N1, is an inactivated monovalent influenza virus vaccine, indicated for active immunization of persons 18 through 64 years of age at increased risk of exposure to the H5N1 influenza virus subtype.

Human Response

• Vaccination Protocol: A randomized, placebo-controlled, double-blind, clinical trial was conducted in healthy adults ranging in ages 18 through 64 in the United States. The subjects received an injection of the vaccine formulation A/Vietnam/1203/2004 (H5N1, clade 1), followed by another dose of the same formulation 28 days later
• Immune Response Assay Type: HI antibody assay
• Side Effects: Most side effects were mild and included pain, tenderness, redness and swelling of the injection site. These local effects were resolved in three days after vaccination. Systemic reactions due to vaccination were also mild to moderately severe.