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Virus Therapy

Flu Vaccine for Seasonal Influenza

Phase 4

Waitlist Available

Led By Tal Einav, PhD

Research Sponsored by Tal Einav

Eligibility Criteria Checklist

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

Must have

Be between 18-64 years of age

Be between 18 and 65 years old

Must not have

Infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus

Inability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 30, and 90 days post-vaccination

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study the effects of updating the seasonal influenza vaccine each year. They will compare the responses of people who received the 2023 vaccine in different time periods to see if the late-season

Who is the study for?

This trial is for individuals who are interested in helping to compare the effectiveness of different seasonal flu vaccines. There aren't specific inclusion or exclusion criteria provided, but typically participants should be healthy, not have allergies to vaccine components, and must not have received the current season's flu vaccine.

What is being tested?

The study aims to understand how effective the late-season administration of the 2023 influenza vaccine is compared to both its standard timing earlier in fall 2023 and next season's (2024) formulation given at standard times.

What are the potential side effects?

Common side effects from flu vaccines like Fluzone include soreness at injection site, headache, fever, nausea, muscle aches. Serious side effects are rare but can include allergic reactions.

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 64 years old.

Exclusion Criteria

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

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I am infected with HIV, hepatitis B, or hepatitis C.

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I am unable to understand or sign the consent form.

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I am not under 18, over 65, pregnant, or nursing.

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I have a history of specific types of anemia.

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I do not have uncontrolled diabetes, heart, kidney, liver diseases, cancer, infections, or blood clotting disorders.

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I haven't donated blood or undergone leukapheresis recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 30, and 90 days post-vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 30, and 90 days post-vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 30, and 90 days post-vaccination for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Magnitude of antibody response post-vaccination

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: Late season influenza vaccineExperimental Treatment1 Intervention

Every participant receives the 2023 influenza vaccine between May-June 2024, and then the 2024 influenza vaccine in September-October 2024. Blood draws are taken at Day 0, 30, and 90 post-vaccination.

0 / 7Eligibility criteria met