• Vaccine Name: FluLaval
• Target Pathogen: Influenza virus
• Target Disease: Influenza (flu)
• Product Name: Influenza Virus Vaccine
• Tradename: FluLaval
• Manufacturer: ID Biomedical Corporation of Quebec
• Vaccine Ontology ID: VO_0000043
• CDC CVX code: 141
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1739)
• Host Species for Licensed Use: Human
• Antigen: Inactivated influenza virus subtypes A and type B
• Preparation: FLULAVAL is a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs. Each of the influenza virus strains is produced and purified separately. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate (FDA: FluLaval).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: FLULAVAL should be stored between 36 and 46 degrees Fahrenheit. DO NOT FREEZE. The multi-dose vial should be shaken vigorously before each administration.
• Approved Age for Licensed Use: Ages 18 and older (FDA: FluLaval)
• Contraindication: FLULAVAL 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 FLULAVAL, or who has had a life threatening reaction to previous influenza vaccination (FDA: FluLaval).
• Description: FLULAVAL is an inactivated influenza virus vaccine indicated for active immunization of adults (18 years 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 randomized controlled clinical trial including 1,000 subjects with ages 18 -65 years in the United States. These subjects were randomized to receive FLULAVAL or a US-licensed trivalent, inactivated influenza virus vaccine (FLUZONE) .
• Immune Response: The analysis of the following co-primary endpoints was performed for each HA antigen contained in the vaccine: 1) assessment of the lower bounds of 2-sided 95% confidence intervals for the proportion of subjects with HI antibody titers of ≥1:40 after vaccination, and 2) assessment of the lower bounds of 2-sided 95% confidence intervals for rates of seroconversion (defined as a 4-fold increase in post-vaccination HI antibody titer from pre-vaccination titer ≥1:10, or an increase in titer from <1:10 to ≥1:40) (FDA: FluLaval).
• Immune Response Assay Type: HI antibody assay
• Side Effects: The most common local and systemic adverse events were pain, redness, and/or swelling at the injection site, headache, fatigue, myalgia, low grade fever, and malaise.

Human Response

• Vaccination Protocol: A randomized, blinded, and controlled clinical trial was conducted in Canada and included a sample population of 658 adults ages 50years and older. This study compared four vaccine groups: FLULAVAL, a similar investigational formulation of FLULAVAL with reduced thimerosal, and 2 Canadian-licensed trivalent influenza vaccines (FDA: FluLaval).
• Immune Response: The serum Hemagglutination-Inhibitng (HI) antibody responses to FLULAVAL met the pre-specified seroconversion criteria for all 3 virus strains (A/Brisbane/59/2007 (H1N1)-like virus (A/Brisbane/59/2007 IVR-148), A/Brisbane/10/2007 (H3N2)-like virus (A/Uruguay/716/2007 NYMC X-175C), and B/Florida/4/2006-like virus (B/Florida/4/2006)), and also the pre-specified criterion for the proportion of subjects with HI titers ≥1:40 for both influenza A viruses. In both trials, both FLULAVAL and the comparator vaccine did not meet the pre-specified criterion for the proportion of subjects with HI titers ≥1:40 for the influenza B virus (FDA: FluLaval).
• Immune Response Assay Type: HI antibody assay
• Side Effects: The most common local adverse effects included: pain, redness and swelling. The most common systemic adverse effects were headache, fatigue and myalgia. Due to the trial featuring a sample ages 50 years and older, there was a longer safety follow-up that helped to show more spontaneous adverse event reports as compared to the United States trial.