CT18 Infant Influenza Priming Study in Vaccine Naive Infants

Children under 24 months of age suffer from an influenza burden (high morbidity and mortality) similar to that of the elderly, and have been identified as a high priority target for vaccination programs by Canada's National Advisory Committee on Immunization. There is evidence that a person's first exposure to influenza antigens may have long-term implications for protection.

This is a randomized, controlled, observer-blind study that will assign participants to one of three groups. Group 1 will receive MF59-adjuvanted influenza vaccine (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 2 will receive QIV (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 3 will receive MF59-adjuvanted IV (two doses one month apart) in the fall of year 1, followed by MF59-adjuvanted IV (one dose) in the fall of year 2.

Inclusion criteria

• Parent/LAR is willing and able to give informed consent for participation in the trial.
• Male or Female, aged six months to 23 months.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion criteria

• Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
• Prior receipt of an influenza vaccine
• History of laboratory-confirmed influenza infection, by parent/LAR report
• Hypersensitivity to any vaccine component of products used in this study (see product monographs)
• Immunodeficiency or autoimmune disease