Clinical trial NCT03669627: CT18 Infant Influenza Priming Study in Vaccine Naive Infants
Official title: A Randomized Controlled Observer Blind Trial to Compare the Immunogenicity and Acceptability of a MF59-adjuvanted Influenza Vaccine Compared to an Inactivated Influenza Vaccine as a Preferred Influenza Vaccine Priming Strategy for Naive Infants 6 to <24 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: infants
priming
Fluad
Fluzone
Lead sponsor: Canadian Immunization Research Network
Sponsor class: NETWORK
Collaborators: name: Provincial Health Services Authority
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Université de Montréal
name: Canadian Center for Vaccinology
name: CHU de Quebec-Universite Laval
name: Dalhousie University
First posted: 2018-09-13
Enrollment: 159
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Serum hemagglutination inhibition (HI) antibody titers
timeFrame: Before and after priming with the various vaccine combinations at day 393.
Secondary outcomes:
measure: Adverse Events (AEs)
timeFrame: Days 0 to 545
Other outcomes:
measure: Vaccine acceptability: parent/Legally Authorized Representative (LAR) questionnaire
timeFrame: Days 56, 180, 393, and 545
measure: Cell-Mediated Immunity
timeFrame: Days 0, 56, 180, 365, 393, 545
Locations:
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center, BC Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Montréal
country: Canada
facility: Research Institute of the McGill University health Centre
state: Quebec
city: Québec
country: Canada
facility: Équipe de recherche en vaccination CHU de Québec-Université Laval
state: Quebec
Study officials:
affiliation: Dalhousie University, Canadian Center for Vaccinology
name: Joanne M Langley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BC Children's Hospital, UBC
name: Soren Gantt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: