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CT18 Infant Influenza Priming Study in Vaccine Naive Infants

NCT03669627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-03-28

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

aTIV Primer

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

BIOLOGICAL

QIV Primer

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

BIOLOGICAL

aTIV Booster

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

BIOLOGICAL

QIV Booster

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

Sponsors & Collaborators

  • Provincial Health Services Authority

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • Canadian Center for Vaccinology

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Canadian Immunization Research Network

    lead NETWORK

Principal Investigators

  • Joanne M Langley, MD · Dalhousie University, Canadian Center for Vaccinology

  • Soren Gantt, MD, PhD · BC Children's Hospital, UBC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-07-21
Completion
2021-07-21

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03669627 on ClinicalTrials.gov