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Flu Vaccine for Melanoma Patients

Phase 4
Waitlist Available
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
Have a diagnosis of locally advanced or metastatic melanoma
Be older than 18 years old
Must not have
Have a history of solid organ or bone marrow transplant
Have HIV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21-42 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will assess the effectiveness of the influenza vaccine in different groups of people.

Who is the study for?
This trial is for adults who can consent and have advanced or metastatic melanoma. They shouldn't be allergic to flu vaccines, haven't had a flu shot in the last 6 months, aren't on strong immune system-suppressing drugs, don't have HIV, haven’t had an organ or bone marrow transplant, and aren't in other blood-drawing studies.
What is being tested?
The study is testing how well the inactivated influenza vaccine works for people with melanoma. It's a prospective study where participants know they're getting the flu vaccine to see their body's response to it.
What are the potential side effects?
While not specified here, common side effects of the flu vaccine may include soreness at injection site, fever, muscle aches, and feeling tired or unwell temporarily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma has spread beyond its original site.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a solid organ or bone marrow transplant.
Select...
I am HIV positive.
Select...
I need medications like prednisone or methotrexate for my condition.
Select...
I need a treatment that boosts my immune system to fight cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21-42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21-42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neutralizing antibody response

Side effects data

From 2016 Phase 1 trial • 100 Patients • NCT02438423
80%
Pruritis (itching) (grade 1)
56%
Tenderness (grade 1)
32%
Redness/Erythema (grade 1)
24%
Headache (grade 1)
24%
Fever (grade 1)
16%
Pain (grade 1)
12%
Malaise (grade 2)
8%
Arthralgia (grade 1)
8%
Fatigue
8%
Joint pain (arthralgia) (grade 1)
8%
Sweating (grade 1)
8%
Redness/Erythema (grade 2)
8%
Fatigue (grade 2)
4%
Tooth infection (grade 1)
4%
Neutropenia (grade 2)
4%
Joint pain (Arthralgia) (grade 2)
4%
Swelling/Induration (grade 1)
4%
Elevated AST (grade 4)
4%
Anemia (grade 1)
4%
Swelling/Induration (grade 2)
4%
URI (grade 1)
4%
Toe infection (grade 1)
4%
Hypertension (grade 2)
4%
Severe acute enteritis
4%
Body ache (myalgia) (grade 1)
4%
Conjunctivitis (grade 1)
4%
Nausea (grade 2)
4%
Tenderness (grade 3)
4%
Acute enteritis
4%
Elevated CK (grade 4)
4%
Nausea (grade 1)
4%
Leukopenia (grade 1)
4%
Presyncope (grade 1)
4%
Hypertension (grade 1)
4%
Elevated ALT AST (grade 1)
4%
Tenderness (grade 2)
4%
Pruritis (grade 2)
4%
Pain (grade 2)
100%
80%
60%
40%
20%
0%
Study treatment Arm
IIV Delivered by MN Patch by Subject
Placebo MN Patch by Study Staff
IIV Delivered by MN Patch by Study Staff
IIV Delivered IM by Study Staff

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
Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inactivated influenza vaccine
2015
Completed Phase 1
~2960

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,077 Previous Clinical Trials
42,720,045 Total Patients Enrolled
E. John Wherry, PhDPrincipal InvestigatorUniversity of Pennsyvlania
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Viral Vaccines
250 Patients Enrolled for Viral Vaccines

Media Library

Inactivated influenza vaccine Clinical Trial Eligibility Overview. Trial Name: NCT03315975 — Phase 4
Viral Vaccines Research Study Groups: Influenza vaccination cohort
Viral Vaccines Clinical Trial 2023: Inactivated influenza vaccine Highlights & Side Effects. Trial Name: NCT03315975 — Phase 4
Inactivated influenza vaccine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03315975 — Phase 4
~3 spots leftby Jul 2025
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