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Virus Therapy
Adjuvanted vs Standard Vaccine for Flu
Phase 4
Waitlist Available
Led By Mark Loeb, MD, MSc.
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group A: Healthy children aged 6 months to 72 months
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing whether a more effective influenza vaccine can help protect a community from the virus.
Who is the study for?
This trial is for healthy Hutterite children aged 6 months to 72 months in Alberta and Saskatchewan, as well as their household members. Children with severe allergies to flu vaccine components, a history of Guillain-Barré syndrome after a flu shot, or egg-related hypersensitivity should not participate. Aspirin users within the last 30 days are also excluded.
What is being tested?
The study compares two types of flu vaccines: Fluad (an adjuvanted vaccine) and Fluzone (a standard inactivated influenza vaccine). It aims to see if Fluad offers better community-wide protection against the flu among Hutterite colonies through random assignment.
What are the potential side effects?
Possible side effects include reactions at the injection site like pain and swelling, fever, muscle aches, headache, fatigue. Severe allergic reactions are rare but can occur with symptoms such as difficulty breathing or hives.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is healthy and between 6 months to 6 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Adjuvanted Influenza VaccineExperimental Treatment1 Intervention
Fluad
Group II: Quadrivalent Influenza VaccineActive Control1 Intervention
Fluzone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza A virus A/Switzerland/9715293/2013 NIB-88 (H3N2) antigen (formaldehyde inactivated)
FDA approved
Find a Location
Who is running the clinical trial?
University of CalgaryOTHER
805 Previous Clinical Trials
881,532 Total Patients Enrolled
McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,610,741 Total Patients Enrolled
University of SaskatchewanOTHER
253 Previous Clinical Trials
151,660 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken aspirin or products containing salicylate in the last 30 days.You had a severe allergic reaction to the flu vaccine or any of its parts before.I developed Guillain-Barré syndrome within 8 weeks after getting a flu shot.You have a severe allergic reaction to eggs that causes hives, swelling, difficulty breathing, low blood pressure, or shock.My child is healthy and between 6 months to 6 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Adjuvanted Influenza Vaccine
- Group 2: Quadrivalent Influenza Vaccine
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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