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| Name | Class |
|---|---|
| Provincial Health Services Authority British Columbia | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| Université de Montréal | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: aTIV primer, QIV booster | Active Comparator | 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. |
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| Group 2: QIV primer, QIV booster | Other | 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. |
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| Group 3: aTIV primer, aTIV booster | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aTIV Primer | Biological | MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before and after priming with the various vaccine combinations at day 393. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Measure local and systemic solicited and unsolicited adverse events following each vaccine dose, and severe AE throughout the study. | Days 0 to 545 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 56, 180, 393, and 545 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne M Langley, MD | Dalhousie University, Canadian Center for Vaccinology | Principal Investigator |
| Soren Gantt, MD, PhD | BC Children's Hospital, UBC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine Evaluation Center, BC Children's Hospital | Vancouver | British Columbia | V5Z 4H4 | Canada | ||
| IWK Health Centre |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Canadian Center for Vaccinology | OTHER |
| CHU de Quebec-Universite Laval | OTHER |
| Dalhousie University | OTHER |
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.
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| QIV Primer | Biological | Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart |
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| aTIV Booster | Biological | MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2 |
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| QIV Booster | Biological | Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2 |
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| Cell-Mediated Immunity | To assess cell mediated immune responses to three influenza immunization two priming schedules in vaccine naïve infants. | Days 0, 56, 180, 365, 393, 545 |
| Halifax |
| Nova Scotia |
| B3K 6R8 |
| Canada |
| Research Institute of the McGill University health Centre | Montreal | Quebec | H9H 4Y6 | Canada |
| Équipe de recherche en vaccination CHU de Québec-Université Laval | Québec | Quebec | G1E 7G9 | Canada |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |