CT18 Infant Influenza Priming Study in Vaccine Naive Infants
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1: aTIV primer, QIV 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. |
Biological: aTIV Primer
MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart
Other Names:
Biological: QIV Booster
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Other Names:
|
| Other: Group 2: QIV primer, 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
Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart
Other Names:
Biological: QIV Booster
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Other Names:
|
| Experimental: Group 3: aTIV primer, aTIV 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
MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart
Other Names:
Biological: aTIV Booster
MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Serum hemagglutination inhibition (HI) antibody titers [Before and after priming with the various vaccine combinations at day 393.]
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.
Secondary Outcome Measures
- Adverse Events (AEs) [Days 0 to 545]
Measure local and systemic solicited and unsolicited adverse events following each vaccine dose, and severe AE throughout the study.
Other Outcome Measures
- Vaccine acceptability: parent/Legally Authorized Representative (LAR) questionnaire [Days 56, 180, 393, and 545]
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.
- Cell-Mediated Immunity [Days 0, 56, 180, 365, 393, 545]
To assess cell mediated immune responses to three influenza immunization two priming schedules in vaccine naïve infants.
Eligibility Criteria
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.
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Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vaccine Evaluation Center, BC Children's Hospital | Vancouver | British Columbia | Canada | V5Z 4H4 |
| 2 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 3 | Research Institute of the McGill University health Centre | Montréal | Quebec | Canada | H9H 4Y6 |
| 4 | Équipe de recherche en vaccination CHU de Québec-Université Laval | Québec | Quebec | Canada | G1E 7G9 |
Sponsors and Collaborators
- Canadian Immunization Research Network
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT18