CT18 Infant Influenza Priming Study in Vaccine Naive Infants
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring infants, priming, Fluad, Fluzone
Eligibility Criteria
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
Sites / Locations
- Vaccine Evaluation Center, BC Children's Hospital
- IWK Health Centre
- Research Institute of the McGill University health Centre
- Équipe de recherche en vaccination CHU de Québec-Université Laval
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Other
Experimental
Group 1: aTIV primer, QIV booster
Group 2: QIV primer, QIV booster
Group 3: aTIV primer, aTIV booster
Two doses (0.25 mL) aTIV (FLUAD )received one month apart in year 1. One dose (0.5 mL) QIV (Fluzone) received as booster in year 2.
Standard of care control group: Two doses (0.5 mL) QIV (Fluzone) received one month apart in year 1. One dose (0.5 mL) QIV (Fluzone) received as booster in year 2.
This arm is experimental in that some participants will be receiving the MF59-adjuvanted TIV (FLUAD) in year two of the study, after the age of two years, which is off label. Two doses (0.25 mL) TIV (FLUAD) received one month apart in year 1. One dose (0.25 mL) TIV (FLUAD) received as booster in year 2.