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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks after receipt of qiv
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-6 weeks after receipt of qiv
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks after receipt of qiv
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Seroprotection rate (SPR) for B/Victoria vaccine strains
Secondary outcome measures
Geometric mean titre (GMT) for A/H1N1 vaccine strains
Geometric mean titre (GMT) for A/H3N2 vaccine strains
Geometric mean titre (GMT) for B/Victoria vaccine strains
+12 moreTrial 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child can attend and complete all study procedures.My child hasn't had a live vaccine in the last 28 days and won't get one during the study.The child has already gotten the flu shot for the 2018-19 flu season.My child may have a weak immune system.My child has not taken strong steroids by mouth or injection in the last 6 weeks.The child has already participated in the TITRE I study in British Columbia or Quebec.My child's guardian can fluently speak English or French.My child received immune globulin or blood products in the last 6 weeks.My child has not had any vaccines other than the study vaccine in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: influenza vaccine recipients
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has the opportunity to participate in this experimental procedure?
"Prospective enrollees must possess flu-like symptoms caused by the influenza virus and have an age between 10 to 13. 55 participants are sought for this trial in total."
Answered by AI
Does this clinical investigation include geriatric participants?
"This research trial is designed for participants aged between 10 and 13, with 43 studies tailored to those under 18 and 78 trials targeting the elderly population of 65 years or older."
Answered by AI
Are there still open opportunities for participants in the experiment?
"As per clinicaltrials.gov, this trial is not presently accepting participants; it was first posted on December 1st 2018 and last modified on July 28th 2022. Nevertheless, 124 other trials are actively enrolling patients at the current time."
Answered by AI
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