Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of MF59C.1-adjuvanted Subunit Influenza Vaccine or Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months

This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to <36 months.

Inclusion Criteria:

• Male and female previously unvaccinated healthy children aged 6 to <36 months.

Exclusion Criteria:

• Any known or suspected impairment of the immune system, any serious disease.
• Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1.