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Virus Therapy

Influenza Vaccine for Flu

Phase 4
Recruiting
Led By E.John Wherry, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Active malignancy
Use of immunosuppressing medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will help researchers understand why some people don't respond well to the flu vaccine, so that they can eventually find a way to improve the vaccine.

Who is the study for?
This trial is for adults who can consent and need a flu shot as part of their regular health care. It's not for those with a fever, cancer, on drugs that suppress the immune system, who've donated blood recently or had a flu shot in the last 6 months, or have allergies to flu vaccines.
What is being tested?
The study involves giving participants an influenza vaccine and then taking samples of their blood at set times afterwards to analyze how their immune cells respond to the vaccination.
What are the potential side effects?
Common side effects from the influenza vaccine may include soreness at injection site, mild fever, muscle pains, and feeling tired. Severe allergic reactions are rare but possible.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have cancer.
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I am currently taking medication that suppresses my immune system.
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I do not have a fever or illness at the time of vaccination.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041
8%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
1%
Acute pulmonary embolism and acute deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

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 vaccination cohortExperimental Treatment1 Intervention
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza vaccination
2017
Completed Phase 4
~153210

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,075 Previous Clinical Trials
42,719,771 Total Patients Enrolled
E.John Wherry, PhDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

Influenza vaccination (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03346772 — Phase 4
Flu Vaccine Research Study Groups: Influenza vaccination cohort
Flu Vaccine Clinical Trial 2023: Influenza vaccination Highlights & Side Effects. Trial Name: NCT03346772 — Phase 4
Influenza vaccination (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03346772 — Phase 4
~6 spots leftby Jul 2025
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