CT18 Infant Influenza Priming Study in Vaccine Naive Infants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Influenza
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomly assigned to one of three groups: Group 1 will receive aTIV as a primer and QIV as a booster, Group 2 will receive QIV as both primer and booster, and Group 3 will receive aTIV as both primer and booster.Masking: Single (Investigator)Masking Description: Observer-blindPrimary Purpose: Prevention
Participation Requirements
- Age
- Younger than 623 years
- Gender
- Both males and females
Description
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 ...
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.
Tracking Information
- NCT #
- NCT03669627
- Collaborators
- Provincial Health Services Authority
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Université de Montréal
- Canadian Center for Vaccinology
- CHU de Quebec-Universite Laval
- Dalhousie University
- Investigators
- Principal Investigator: Joanne M Langley, MD Dalhousie University, Canadian Center for Vaccinology Principal Investigator: Soren Gantt, MD, PhD BC Children's Hospital, UBC
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