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Trial record 71 of 112 for:    mf59

CT18 Infant Influenza Priming Study in Vaccine Naive Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03669627
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborators:
Provincial Health Services Authority
McGill University Health Center
Université de Montréal
Canadian Center for Vaccinology
McMaster University
CHU de Quebec-Universite Laval
Dalhousie University
Information provided by (Responsible Party):
Joanne Langley, Canadian Immunization Research Network

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
Influenza Biological: aTIV Primer Biological: QIV Primer Biological: aTIV Booster Biological: QIV Booster 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Masking Description: Observer-blind
Primary Purpose: Prevention
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
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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 Name: FLUAD Pediatric®

Biological: QIV Booster
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Other Name: Fluzone® Quadrivalent

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 Name: Fluzone® Quadrivalent

Biological: QIV Booster
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Other Name: Fluzone® Quadrivalent

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 Name: FLUAD Pediatric®

Biological: aTIV Booster
MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2
Other Name: FLUAD Pediatric®




Primary Outcome Measures :
  1. Serum hemagglutination inhibition (HI) antibody titers [ Time Frame: 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 :
  1. Adverse Events (AEs) [ Time Frame: 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:
  1. Vaccine acceptability: parent/Legally Authorized Representative (LAR) questionnaire [ Time Frame: 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.

  2. Cell-Mediated Immunity [ Time Frame: Days 0, 56, 180, 365, 393, 545 ]
    To assess cell mediated immune responses to three influenza immunization two priming schedules in vaccine naïve infants.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669627


Contacts
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Contact: Jill Mutch, BScN 902-470-3860 jill.mutch@iwk.nshealth.ca

Locations
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Canada, British Columbia
Vaccine Evaluation Center, BC Children's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Soren Gantt, MD         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Catherine Brown, RN    902-470-7015    catherine.brown@iwk.nshealth.ca   
Canada, Ontario
McMaster University Medical Centre, Michael DeGroote Centre for Learning & Discovery Not yet recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Mark Loeb, MD         
Canada, Quebec
Research Institute of the McGill University health Centre Not yet recruiting
Montréal, Quebec, Canada, H9H 4Y6
Contact: Caroline Quach, MD         
Équipe de recherche en vaccination CHU de Québec-Université Laval Not yet recruiting
Québec, Quebec, Canada, G1E 7G9
Contact: Marc Dionne, MD         
Sponsors and Collaborators
Canadian Immunization Research Network
Provincial Health Services Authority
McGill University Health Center
Université de Montréal
Canadian Center for Vaccinology
McMaster University
CHU de Quebec-Universite Laval
Dalhousie University
Investigators
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Principal Investigator: Joanne M Langley, MD Dalhousie University, Canadian Center for Vaccinology
Principal Investigator: Soren Gantt, MD, PhD BC Children's Hospital, UBC

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Responsible Party: Joanne Langley, Principal Investigator, Canadian Immunization Research Network
ClinicalTrials.gov Identifier: NCT03669627     History of Changes
Other Study ID Numbers: CT18
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joanne Langley, Canadian Immunization Research Network:
infants
priming
Fluad
Fluzone

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs