Flucelvax, Influenza Virus Vaccine

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved November 2012

Specific Treatments:

influenza virus subtypes A and type B

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General Information

Flucelvax is an inactivated cell-culture-derived vaccine for influenza A and B. Cell-culture manufacturing technology provides an alternative production method to traditional egg-based production, utilizing a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.

Flucelvax is specifically indicated for active immunization in adults aged 18 years and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

Flucelvax is supplied as a solution for intramuscular injection. The recommended dose is a single 0.5 mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.

Clinical Results

FDA Approval
The FDA approval of Flucelvax was based on the following study results:
Efficacy against Culture-Confirmed Influenza
A multinational (US, Finland, and Poland), randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Flucelvax during the 2007-2008 influenza season. A total of 11,404 adults aged 18 through 49 years were enrolled to receive Flucelvax, Agriflu or placebo. Efficacy was assessed by the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine and prevention of influenza illness caused by all influenza viruses compared to placebo. Antigenically Matched Strains: Flucelvax: 7 subjects with influenza (0.19% attack rate); placebo: 44 subjects with influenza (1.14% attack rate); 83.8% efficacy rate for Flucelvax. All Culture-Confirmed Influenza: Flucelvax: 42 subjects with influenza (1.11% attack rate); placebo: 140 subjects with influenza (3.64% attack rate); 55% efficacy rate for Flucelvax.
Immunogenicity in Adults 18 through 64 Years of Age
Data evaluating immunogenicity in adults 18 through 64 years of age were derived from 3 clinical studies, including 1,353 subjects that received Flucelvax. Immune responses measured by hemagglutination inhibition (HI) antibody titers to each virus strain in the vaccine were evaluated in sera obtained 21 days after administration of Flucelvax. Flucelvax demonstrated comparable immunogenicity to Agriflu for all three strains post-vaccination.
Non-inferiority in Adults 18 through 64 Years of Age
Non-inferiority of Flucelvax to Agriflu was demonstrated for HI antibody responses to all three strains for both post-vaccination geometric mean titer (GMT) ratios and seroconversion rates (i.e. the lower limit of the two-sided 95% CI for the ratio of the GMTs (Flucelvax/ Agriflu was >0.67; and the lower limit of the two-sided 95% CI for the difference between the seroconversion rates was >-10%).

Side Effects

Adverse events associated with the use of Flucelvax may include, but are mot limited to, the following:

  • injection site pain
  • injection site erythema
  • headache
  • fatigue
  • myalgia
  • malaise

Mechanism of Action

Flucelvax is an inactivated cell-culture-derived vaccine for influenza A and B. Cell-culture manufacturing technology provides an alternative production method to traditional egg-based production, utilizing a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.

Additional Information

For additional information regarding Flucelvax or influenza, please visit the Flucelvax web page.