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Virus Therapy

Influenza Vaccine for Flu

Phase 4

Recruiting

Led By Edmund K Waller, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy adults

Adults able to provide consent on their own

Must not have

Individuals who are vulnerable to coercion or undue influence (human fetuses, or neonates of uncertain viability or non-viable neonates, minors/children, and cognitively impaired adults) will not be eligible for participation in this study.

Cognitively impaired or individuals with impaired decision-making capacity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study days: 0, 7, 28, 90, 365

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests the effectiveness of a flu vaccine in healthy adults by measuring the response of their immune systems.

Who is the study for?

This trial is for healthy adults who can consent to participate, from any gender, race, or ethnic group. It's not for those vulnerable to coercion (like minors or cognitively impaired), pregnant/nursing women, prisoners, or anyone unable to consent.

What is being tested?

The study tests the immune response to a killed flu vaccine in healthy people. It's an open label and single arm observational study where participants get the flu shot and provide blood and bone marrow samples over a year.

What are the potential side effects?

While specific side effects are not listed here, common reactions to flu vaccines include soreness at injection site, feverish feelings, muscle pains and occasionally mild flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy adult.

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I can make my own medical decisions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am an adult capable of making my own decisions and not easily influenced.

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I have difficulty making decisions due to cognitive issues.

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I am unable to give consent for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study days: 0, 7, 28, 90, 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study days: 0, 7, 28, 90, 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and study days: 0, 7, 28, 90, 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Bone marrow persistence of B-Cell response to Influenza

Changes in clonal diversity of B-Cell response to Influenza in blood

Changes in clonal diversity of B-Cell response to Influenza in bone marrow

+3 more

Side effects data

From 2015 Phase 4 trial • 985 Patients • NCT02290691

64%

Tenderness

48%

Pain

35%

Redness

29%

Swelling

24%

Itching

20%

Muscle Ache

15%

Headache

12%

Fatigue

10%

Bruising

Chills

Nausea

Fever

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Needle- Free

Needle and Syringe

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: Influenza VaccineExperimental Treatment1 Intervention

Healthy male and female individuals aged 18-64 years will be eligible to participate in this study. Subjects will be offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria are met each year. Subjects will be re-screened to verify continued eligibility and re-consented prior to subsequent participation and will receive new subject identifiers

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Influenza Vaccine

2022

Completed Phase 4

~16660

0 / 5Eligibility criteria met