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Virus Therapy

Live Attenuated Influenza Vaccine for Flu

Phase 4
Recruiting
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,
Must not have
Cardiovascular disease (excluding isolated hypertension)
Congestive heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a heart condition other than just high blood pressure.
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I have been diagnosed with congestive heart failure.
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I have had a respiratory infection in the last month.
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I have a long-term condition affecting my lungs, liver, kidneys, nervous system, blood, or metabolism.
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I have had Guillain-Barre syndrome in the past.
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I have a condition or take medication that weakens my immune system.

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

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

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: 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
1,655 Previous Clinical Trials
2,444,133 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
~5 spots leftby Dec 2025
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