• Vaccine Name: Afluria
• Target Pathogen: Influenza virus
• Target Disease: Influenza (flu)
• Product Name: Influenza Virus Vaccine
• Tradename: Afluria
• Manufacturer: CSL Limited
• Vaccine Ontology ID: VO_0000006
• CDC CVX code: 141, 140
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License # 1764)
• Host Species for Licensed Use: Human
• Antigen: The vaccine is a purified, inactivated, split virion influenza vaccine made by “splitting” the purified, inactivated, whole virus to form fragments. This process reduces the number of adverse events experienced with whole virus vaccines, yet leaves the surface antigens and structural proteins in their original antigenic form. This vaccine includes Influenza virus subtypes A and type B, and is specifically formulated to contain A/California/7/2009 (H1N1), A/Wisconsin/15/2009 (H3N2) and B/Brisbane/60/2008 (B Strain) (FDA: Afluria).
• Preparation: Afluria is a sterile suspension prepared from influenza virus. The virus is harvested from the allantoic fluid of embryonic chicken eggs, and purified in a sucrose density gradient using a continous flow zonal centrifuge. The purified virus is inactivated with beta propiolactone. The virus particles are disrupted using sodium taurdeoxycholate to produce a "split virion." The disrupted virus is further purified and suspended in a phosphate-buffered isotonic solution (FDA: Afluria).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: ALFURIA in a multi-dose vial should be stored at a temperature of 36 to 46 degrees Fahrenheit. Both the single and multi-dose vials should be shaken thoroughly before administration.
• Approved Age for Licensed Use: 6 months and older (FDA: Afluria).
• Contraindication: AFLURIA should not administered to anyone with known hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or in anyone who has had a life-threatening reaction to previous influenza vaccination (FDA: Afluria).

Human Response

• Host Strain: healthy human subjects in USA
• Host age: ages 18 to less than 65 years old
• Vaccination Protocol: A randomized, double-blinded, placebo-controlled, multicenter study in healthy subjects ages 18 to less than 65 years in the United States. Subjects received AFLURIA in either a single-dose or multi-dose formulation.
• Immune Response: The single-dose and multi-dose formulations elicited similar immune responses.
• Immune Response Assay Type: HI antibody assay
• Side Effects: The most common local side-effects were tenderness, pain, redness and swelling of the injection site. Common systemic reactions included: headache, malaise, and muscle aches. Severe allergic reactions such as anaphylactic shock have been observed in individuals vaccinated with AFLURIA.

Human Response

• Vaccination Protocol: A randomized, controlled study that enrolled 275 healthy subjects ages 65 years and older in the United Kingdom. This study compared AFLURIA® with a European-licensed trivalent inactivated influenza vaccine as an active control (FDA: Afluria).
• Immune Response: The post-hoc analysis of serum HI antibody responses showed that the lower bound of the 95% confidence internals (CI) for subjects with HI antibody titers of 1:40 or greater after vaccination exceeds 70% for each of the three strains (H1N, H3N2, and B) in the vaccine. In human subjects aged more than 65 years, significant serum hemagglutination-inhibiting (HI) antibody responses to AFLURIA were induced for all three virus strains (HiNi, H3N2, and B), but the level of the HI antibody response appeared lower than the similar study conducted in the ages 18 to less than 65 years (FDA: Afluria).
• Immune Response Assay Type: HI antibody assay
• Side Effects: The recorded side effects of the vaccination were similar to those observed in the United States study regarding AFLURIA.

Human Response

• Vaccination Protocol: A randomized, controlled study that enrolled 406 healthy subjects ages 18 years and older in the United Kingdom (FDA: Afluria).
• Immune Response: The post-hoc analysis of serum HI antibody responses showed that the lower bound of the 95% confidence internals (CI) for subjects with HI antibody titers of 1:40 or greater after vaccination exceeds 70% for each of the three strains (H1N, H3N2, and B) in the vaccine (FDA: Afluria).
• Immune Response Assay Type: HI antibody assay
• Side Effects: Side Effects were similar to those observed in the two previous clinical trials in the United States and the United Kingdom.