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Virus Therapy

Live Attenuated Influenza Vaccine for Flu

Phase 4
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-49 years old
not yet received influenza vaccine for 2019-2020,
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2
Awards & highlights

Study Summary

This trial will help researchers develop a model for influenza infection, by administering the live attenuated influenza vaccine to healthy volunteers and measuring the virus and immune responses in their nasal passages.

Who is the study for?
Healthy adults aged 18-49 who haven't had the flu vaccine for the current season can join. They must be able to consent to participate. People with chronic health issues, recent respiratory infections, heart failure, Guillain-Barre syndrome, pregnancy, egg allergies or contact with immunocompromised individuals cannot join.Check my eligibility
What is being tested?
The study is testing a nasal spray flu vaccine called Flumist Quadrivalent to develop a model of influenza infection. Participants will receive this live vaccine and researchers will collect nasal samples to study virus presence and immune responses.See study design
What are the potential side effects?
As it's a live attenuated vaccine administered nasally, potential side effects may include nasal congestion or runny nose, sore throat, and possibly mild flu-like symptoms as the body responds to the vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 49 years old.
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I have not received the flu vaccine for 2019-2020.
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I am able to understand and sign the consent form.
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I am between 18 and 49 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
cystic fibrosis transmembrane conductance regulator function
influenza virus replication
markers of inflammation

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

Trial Design

1Treatment groups
Experimental Treatment
Group I: open labelExperimental Treatment1 Intervention
FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,278,009 Total Patients Enrolled

Media Library

Flumist Quadrivalent Nasal Product (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04164212 — Phase 4
Influenza Research Study Groups: open label
Influenza Clinical Trial 2023: Flumist Quadrivalent Nasal Product Highlights & Side Effects. Trial Name: NCT04164212 — Phase 4
Flumist Quadrivalent Nasal Product (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04164212 — Phase 4

Frequently Asked Questions

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

Is the age requirement for this study eighteen years or older?

"This clinical trial requires that participants are between 18 and 49 years old. For individuals younger than 18, there are 47 studies available; for seniors aged 65 or more, 81 trials can be found."

Answered by AI

Who meets the eligibility criteria for this experiment?

"This research endeavor is currently accepting 20 individuals between 18 and 49 years old who have not yet been vaccinated for the 2019-2020 influenza season. The necessary qualifications are that applicants must fall within this age range, as well as meet any other prerequisites outlined in the study's protocols."

Answered by AI

Are there openings available for participation in this experiment?

"This trial has expired, having been initially posted on September 1st 2020 and last updated July 14th 2022. Fortunately, there are 124 studies still actively recruiting patients with influenza plus 8 trials for this particular treatment that require participants."

Answered by AI

How many participants will be accepted into this experiment?

"This clinical trial has since closed its recruitment phase. It was initially posted on September 1st 2020 and last updated July 14th 2022. For those seeking alternative studies, there are presently 124 trials for influenza research involving human subjects as well as 8 prospective medical trials with open enrolment criteria."

Answered by AI

Are there any comparable research efforts that have utilized this therapy?

"At present, 8 trials for this medication are running with one of them in its third stage. Stanford University is the hub of these studies but there are an additional 7 research centres also participating."

Answered by AI

Has this therapeutic intervention been accepted by the FDA?

"Data from the Phase 4 trial indicates that this treatment carries a high degree of safety and it was given a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
UAB Lung Health Center
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Dec 2024