Back to results

CT18 Infant Influenza Priming Study in Vaccine Naive Infants

Primary Purpose

Influenza

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

aTIV Primer

QIV Primer

aTIV Booster

QIV Booster

About this trial

This is an interventional prevention trial for Influenza focused on measuring infants, priming, Fluad, Fluzone

Eligibility Criteria

6 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Vaccine Evaluation Center, BC Children's Hospital
IWK Health Centre
Research Institute of the McGill University health Centre
Équipe de recherche en vaccination CHU de Québec-Université Laval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Experimental

Arm Label

Group 1: aTIV primer, QIV booster

Group 2: QIV primer, QIV booster

Group 3: aTIV primer, aTIV booster

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Events (AEs)

Measure local and systemic solicited and unsolicited adverse events following each vaccine dose, and severe AE throughout the study.

Full Information

NCT ID

NCT03669627

First Posted

September 5, 2018

Last Updated

March 27, 2023

Sponsor

Canadian Immunization Research Network

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03669627

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

July 21, 2021 (Actual)

Study Completion Date

July 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Canadian Immunization Research Network

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

infants, priming, Fluad, Fluzone

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

Investigator

Masking Description

Observer-blind

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: aTIV primer, QIV booster

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group 2: QIV primer, QIV booster

Arm Type

Other

Arm Description

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.

Arm Title

Group 3: aTIV primer, aTIV booster

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

aTIV Primer

Other Intervention Name(s)

FLUAD Pediatric®

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

QIV Primer

Other Intervention Name(s)

Fluzone® Quadrivalent

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

aTIV Booster

Other Intervention Name(s)

FLUAD Pediatric®

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

QIV Booster

Other Intervention Name(s)

Fluzone® Quadrivalent

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum hemagglutination inhibition (HI) antibody titers

Description

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.

Time Frame

Before and after priming with the various vaccine combinations at day 393.

Secondary Outcome Measure Information:

Title

Adverse Events (AEs)

Description

Measure local and systemic solicited and unsolicited adverse events following each vaccine dose, and severe AE throughout the study.

Time Frame

Days 0 to 545

Other Pre-specified Outcome Measures:

Title

Vaccine acceptability: parent/Legally Authorized Representative (LAR) questionnaire

Description

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.

Time Frame

Days 56, 180, 393, and 545

Title

Cell-Mediated Immunity

Description

To assess cell mediated immune responses to three influenza immunization two priming schedules in vaccine naïve infants.

Time Frame

Days 0, 56, 180, 365, 393, 545

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

23 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joanne M Langley, MD

Organizational Affiliation

Dalhousie University, Canadian Center for Vaccinology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Soren Gantt, MD, PhD

Organizational Affiliation

BC Children's Hospital, UBC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vaccine Evaluation Center, BC Children's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4H4

Country

Canada

Facility Name

IWK Health Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

Research Institute of the McGill University health Centre

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H9H 4Y6

Country

Canada

Facility Name

Équipe de recherche en vaccination CHU de Québec-Université Laval

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1E 7G9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

CT18 Infant Influenza Priming Study in Vaccine Naive Infants

We'll reach out to this number within 24 hrs