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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 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
My child is healthy and between 6 months to 6 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Laboratory-confirmed influenza infection

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?

McMaster UniversityLead Sponsor
877 Previous Clinical Trials
2,593,560 Total Patients Enrolled
University of CalgaryOTHER
780 Previous Clinical Trials
839,234 Total Patients Enrolled
University of SaskatchewanOTHER
249 Previous Clinical Trials
151,674 Total Patients Enrolled

Media Library

Fluad (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02871206 — Phase 4
Influenza Research Study Groups: Adjuvanted Influenza Vaccine, Quadrivalent Influenza Vaccine
Influenza Clinical Trial 2023: Fluad Highlights & Side Effects. Trial Name: NCT02871206 — Phase 4
Fluad (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02871206 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults of 20 years and above eligible for enrollment in the experiment?

"This research seeks participants between 6 and 72 months of age."

Answered by AI

Is the current clinical trial a pioneering venture?

"At present, 14 distinct trials for Fluad are running in 10 cities from 3 different countries. The first of these ran in 2016 and was conducted by Pharmacyclics LLC., enrolling 42 patients to reach Phase 2 drug approval. Since then, 159 studies have been finalized."

Answered by AI

Are there any precedents set by prior experiments involving Fluad?

"Currently, there are 14 different trials assessing Fluad's efficacy and safety. From these studies, one is in Phase 3 of clinical testing. While the majority of investigations are based around Miami, Florida, overall 15 locations have active medical trials examining this medication."

Answered by AI

Is Fluad a reliable vaccine for individuals?

"Previous evaluations of Fluad's safety have earned it a score of 3. This is due to its status as an approved medication from Phase 4 trials."

Answered by AI

Is it possible for me to become part of this research project?

"This investigation requires 2500 participants in the 6-72 month age range, who have contracted influenza. Specifically, Group A is expected to receive an intervention and must be composed of young children in good health."

Answered by AI

Are there opportunities to volunteer for this research endeavor?

"At this point in time, patient recruitment for this trial has closed. It was originally listed on November 1st 2016 and the posting had its last amendment made back in January 6th 2017. Thankfully, there are 124 clinical trials recruiting human participants with influenza as well as 14 studies looking to enrol patients who have Fluad."

Answered by AI

How many participants are being recruited to take part in this experiment?

"This trial has now concluded its recruitment phase, with the initial posting date being November 1st 2016 and a final update on January 6th 2017. If you are seeking other studies related to influenza, there are currently 124 human trials and 14 specifically for Fluad actively recruiting participants."

Answered by AI
~300 spots leftby Mar 2025