CT18 Infant Influenza Priming Study in Vaccine Naive Infants
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
1 other identifier
interventional
159
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2021
CompletedMarch 28, 2023
March 1, 2023
2.7 years
September 5, 2018
March 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
Adverse Events (AEs)
Days 0 to 545
Other Outcomes (2)
Vaccine acceptability: parent/Legally Authorized Representative (LAR) questionnaire
Days 56, 180, 393, and 545
Cell-Mediated Immunity
Days 0, 56, 180, 365, 393, 545
Study Arms (3)
Group 1: aTIV primer, QIV booster
ACTIVE COMPARATORTwo 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.
Group 2: QIV primer, QIV booster
OTHERStandard 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.
Group 3: aTIV primer, aTIV booster
EXPERIMENTALThis 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.
Interventions
MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart
Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart
MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Immunization Research Networklead
- Provincial Health Services Authority British Columbiacollaborator
- McGill University Health Centre/Research Institute of the McGill University Health Centrecollaborator
- Université de Montréalcollaborator
- Canadian Center for Vaccinologycollaborator
- CHU de Quebec-Universite Lavalcollaborator
- Dalhousie Universitycollaborator
Study Sites (4)
Vaccine Evaluation Center, BC Children's Hospital
Vancouver, British Columbia, V5Z 4H4, Canada
IWK Health Centre
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne M Langley, MD
Dalhousie University, Canadian Center for Vaccinology
- PRINCIPAL INVESTIGATOR
Soren Gantt, MD, PhD
BC Children's Hospital, UBC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Observer-blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 5, 2018
First Posted
September 13, 2018
Study Start
November 1, 2018
Primary Completion
July 21, 2021
Study Completion
July 21, 2021
Last Updated
March 28, 2023
Record last verified: 2023-03