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Virus Therapy

Influenza Vaccine for Flu

Phase 4

Recruiting

Led By Edmund K Waller, MD, PhD

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

All genders, races and ethnic groups (inclusive of women and minorities) are eligible for this trial, as influenza and the associated range of clinical issues accompanying influenza infection can impact people of all genders, races and ethnic groups. It is anticipated that the distribution of study participants will be diverse with regard to these demographics.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 belong to any gender, race, or ethnic group.

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I can make my own medical decisions.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Vomiting

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Needle- Free

Needle and Syringe

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

2010

Completed Phase 4

~6900

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,483 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,268 Previous Clinical Trials

5,481,042 Total Patients Enrolled

Edmund K Waller, MD, PhDPrincipal InvestigatorEmory University

2 Previous Clinical Trials

47 Total Patients Enrolled

Media Library

Influenza Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05616546 — Phase 4

Influenza Research Study Groups: Influenza Vaccine

Influenza Clinical Trial 2023: Influenza Vaccine Highlights & Side Effects. Trial Name: NCT05616546 — Phase 4

Influenza Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05616546 — Phase 4

Frequently Asked Questions

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

Does this clinical trial accommodate individuals over the age of 50?

"This clinical trial seeks out patients within the 18-49 age range. There are, however, 43 medical studies exclusively for minors and 78 trials targeting elderly citizens."

Answered by AI

Are researchers still recruiting participants for this experiment?

"Data from clinicaltrials.gov suggests that this trial is not recruiting at present, despite having been posted on November 1st 2022 and updated 8 days later. Nonetheless, 124 other studies are presently seeking participants to join their trials."

Answered by AI

Is eligibility for this trial open to applicants like myself?

"This clinical study is aiming to enrol 90 individuals between 18 and 49 years of age, who are currently afflicted with flu caused by the influenza virus. This trial is open to all genders, races and minority groups – as the complications related to influenza may affect people from any background. The composition of participants should reflect a wide range of demographics for maximum efficacy in data collection. Furthermore, only those who can provide independent consent and have no existing health conditions will be considered eligible."

Answered by AI

Does the Influenza Vaccine present any potential risk to individuals?

"Our team at Power has judged that the Influenza Vaccine is highly safe, awarding it a 3 on our scale. This conclusion comes from its Phase 4 status signifying authorization for public use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bone Marrow and Peripheral Blood Immune Responses Study

Edmund Waller 2023. "Bone Marrow and Peripheral Blood Immune Responses Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05616546.

All > Influenza