CT18 Infant Influenza Priming Study in Vaccine Naive Infants

March 27, 2023 updated by: Joanne Langley, Canadian Immunization Research Network

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4H4
        • Vaccine Evaluation Center, BC Children's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Quebec
      • Montréal, Quebec, Canada, H9H 4Y6
        • Research Institute of the McGill University Health Centre
      • Québec, Quebec, Canada, G1E 7G9
        • Équipe de recherche en vaccination CHU de Québec-Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • FLUAD Pediatric®
Biological: QIV Booster
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Other Names:
  • Fluzone® Quadrivalent
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 Booster
Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
Other Names:
  • Fluzone® Quadrivalent
Biological: QIV Primer
Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart
Other Names:
  • 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 Names:
  • FLUAD Pediatric®
Biological: aTIV Booster
MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2
Other Names:
  • FLUAD Pediatric®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and after priming with the various vaccine combinations at day 393.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Days 0 to 545

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Days 56, 180, 393, and 545
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.
Days 0, 56, 180, 365, 393, 545

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Immunization Research Network

Collaborators

CHU de Quebec-Universite Laval
McGill University Health Centre/Research Institute of the McGill University Health Centre
Dalhousie University
Provincial Health Services Authority
Université de Montréal
Canadian Center for Vaccinology

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

July 21, 2021

Study Completion (Actual)

July 21, 2021

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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