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Vaccine

Influenza Vaccine for Flu

Phase 4
Waitlist Available
Led By Danuta M Skowronski, MD
Research Sponsored by British Columbia Centre for Disease Control
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Child has received any live vaccine within 28 days of the study vaccine or is scheduled to receive live vaccine during the study period
Child has known or suspected immunodeficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks after receipt of qiv
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test whether children vaccinated with the B/Yamagata component of the influenza vaccine in 2008-09 are still protected against the B/Victoria component ten years later.

Who is the study for?
This trial is for children in British Columbia or Quebec who participated in the TITRE I study and haven't had their 2018-19 flu shot. They should be generally healthy, able to complete the study, and have a parent/guardian fluent in English/French who can consent.
What is being tested?
The trial tests if kids primed with B/Yamagata flu strain via vaccine years ago now respond well to B/Victoria strain in the updated quadrivalent influenza vaccine for the 2018-19 season.
What are the potential side effects?
Common side effects of flu vaccines include soreness at injection site, mild fever, fatigue, headache, muscle pains. Serious allergic reactions are rare but possible.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child hasn't had a live vaccine in the last 28 days and won't get one during the study.
Select...
My child may have a weak immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks after receipt of qiv
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks after receipt of qiv for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Seroprotection rate (SPR) for B/Victoria vaccine strains

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: influenza vaccine recipientsExperimental Treatment1 Intervention
Participants of an earlier clinical trial (TITRE I) to receive one dose of the 2018-19 quadrivalent inactivated influenza vaccine

Find a Location

Who is running the clinical trial?

British Columbia Centre for Disease ControlLead Sponsor
10 Previous Clinical Trials
2,528 Total Patients Enrolled
Vaccine Evaluation Center, CanadaOTHER
2 Previous Clinical Trials
285 Total Patients Enrolled
Institut National en Santé Publique du QuébecOTHER
9 Previous Clinical Trials
21,602 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
471 Previous Clinical Trials
166,902 Total Patients Enrolled
Danuta M Skowronski, MDPrincipal InvestigatorBC Centre for Disease Control
3 Previous Clinical Trials
342 Total Patients Enrolled

Media Library

2018-19 quadrivalent inactivated influenza vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03753347 — Phase 4
Influenza Research Study Groups: influenza vaccine recipients
Influenza Clinical Trial 2023: 2018-19 quadrivalent inactivated influenza vaccine Highlights & Side Effects. Trial Name: NCT03753347 — Phase 4
2018-19 quadrivalent inactivated influenza vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03753347 — Phase 4
~8 spots leftby Dec 2025
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