Fluad (trivalent influenza vaccine)

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

Company:

Approval Status:

Approved November 2015

Specific Treatments:

influenza A and B

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General Information

Fluad is a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B).

Fluad is specifically indicated for the prevention of seasonal influenza in people 65 years of age and older.

Fluad is supplied as a solution for intramuscular injection. The recommended dose is a single 0.5 mL dose.

Clinical Results

FDA Approval

The FDA approval of Fluad was based on a safety and immunogenicity study of Fluad in comparison to Agriflu. A total of 7,082 subjects were randomized and vaccinated with Fluad or Agriflu. The primary immunogenicity analyses were conducted on all vaccinated subjects with a blood sample collected at Day 22. Non-inferiority of Fluad compared with Agriflu was demonstrated for all three vaccine strains based on pre-defined thresholds for seroconversion rate differences and GMT ratios.

Side Effects

Adverse effects associated with the use of Fluad may include, but are not limited to, the following:

local (injection site) adverse reactions:

  • injection site pain
  • tenderness

systemic adverse reactions

  • myalgia
  • headache
  • fatigue

Mechanism of Action

Fluad is a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B). It is manufactured using an egg-based process and is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil. 

Additional Information

For additional information regarding Fluad or influenza A and B in older individuals, please visit http://www.seqirus.com/