A Phase 2 interventional study of aTIV Primer and QIV Primer in Influenza, sponsored by Canadian Immunization Research Network. Completed at 4 sites in Canada. Open to participants aged 6 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Canadian Immunization Research Network · Phase 2, Interventional, and Prevention
This study evaluates whether priming influenza naive infants, age six to 23 months, with a MF59-adjuvanted (oil in water emulsion) influenza vaccine is preferred to priming with an inactivated unadjuvanted influenza vaccine. All participants will receive a priming vaccine, either MF59-adjuvanted trivalent influenza vaccine (aTIV) or unadjuvanted quadrivalent influenza vaccine (QIV). For the booster shot the following year, two thirds of participants will receive QIV and one third will receive MF59-adjuvanted vaccine.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 159 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Canadian Immunization Research Network is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
Biological: aTIV Primer · Biological: QIV Booster
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.
Biological: QIV Primer · Biological: QIV Booster
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.
Biological: aTIV Primer · Biological: aTIV Booster
MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart
Also known as: FLUAD Pediatric®
Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart
Also known as: Fluzone® Quadrivalent
MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2
Also known as: FLUAD Pediatric®
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Also known as: Fluzone® Quadrivalent
Serum hemagglutination inhibition (HI) antibody titers
Serum HI antibodies to influenza antigens A/H3N2, A/H1N1, and B Yamagata and Victoria lineages will be used to calculate the seroconversion rate and the seroprotection rates.
Time frame: Before and after priming with the various vaccine combinations at day 393.
Adverse Events (AEs)
Measure local and systemic solicited and unsolicited adverse events following each vaccine dose, and severe AE throughout the study.
Time frame: Days 0 to 545
Vaccine acceptability: parent/Legally Authorized Representative (LAR) questionnaire
The Acceptability Questionnaire measures parental opinions about side effects of the study vaccines. There are four questions with a scale range evaluating degree of certainty and one open-ended question with a free text response. There is no total score.
Time frame: Days 56, 180, 393, and 545
Cell-Mediated Immunity
To assess cell mediated immune responses to three influenza immunization two priming schedules in vaccine naïve infants.
Time frame: Days 0, 56, 180, 365, 393, 545
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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