CT18 Infant Influenza Priming Study in Vaccine Naive Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-07-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Observer-blind

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

aTIV Primer

Intervention Type BIOLOGICAL

MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart

QIV Booster

Intervention Type BIOLOGICAL

Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2

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.

Group Type OTHER

QIV Primer

Intervention Type BIOLOGICAL

Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart

QIV Booster

Intervention Type BIOLOGICAL

Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2

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.

Group Type EXPERIMENTAL

aTIV Primer

Intervention Type BIOLOGICAL

MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart

aTIV Booster

Intervention Type BIOLOGICAL

MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2

Interventions

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aTIV Primer

MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart

Intervention Type BIOLOGICAL

QIV Primer

Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart

Intervention Type BIOLOGICAL

aTIV Booster

MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2

Intervention Type BIOLOGICAL

QIV Booster

Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2

Intervention Type BIOLOGICAL

Other Intervention Names

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FLUAD Pediatric® Fluzone® Quadrivalent FLUAD Pediatric® Fluzone® Quadrivalent

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes