A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:

• A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain)
• A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain)
• B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season.

The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes.

A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.

The measures of immunogenicity for each antigen are:

• the geometric mean area (GMA) on Day 0 and Day 21

• the Day 21/Day 0 geometric mean area ratio (GMR)

• the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2

• the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21

  1. Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2.
  2. Significant increase in antibody titer is defined as at least a 50% increase in area.

Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.

Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.

Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).