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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21-42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21-42 days
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 • NCT0243842380%
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%
Joint pain (Arthralgia) (grade 2)
4%
Severe acute enteritis
4%
Nausea (grade 2)
4%
Swelling/Induration (grade 1)
4%
Tooth infection (grade 1)
4%
Neutropenia (grade 2)
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%
Body ache (myalgia) (grade 1)
4%
Conjunctivitis (grade 1)
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
2,082 Previous Clinical Trials
42,727,290 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are participating in other studies that require a lot of blood to be drawn during the same time as this study.You are allergic to the flu vaccine.I have had a solid organ or bone marrow transplant.I have received a flu shot in the last 6 months.I am HIV positive.My melanoma has spread beyond its original site.I need medications like prednisone or methotrexate for my condition.I need a treatment that boosts my immune system to fight cancer.I am an adult who can legally consent.
Research Study Groups:
This trial has the following groups:- Group 1: Influenza vaccination cohort
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.