General Information

Fluad has been approved as trivalent vaccine produced from three influenza virus strains (two subtype A and one type B) and as a quadrivalent vaccine. Fluad Quadrivalent utilizes the same MF59 adjuvant technology as Fluad, but includes an additional strain.

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/