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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21-42 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My melanoma has spread beyond its original site.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Fever (grade 1)
24%
Headache (grade 1)
16%
Pain (grade 1)
12%
Malaise (grade 2)
8%
Joint pain (arthralgia) (grade 1)
8%
Fatigue (grade 2)
8%
Fatigue
8%
Sweating (grade 1)
8%
Arthralgia (grade 1)
8%
Redness/Erythema (grade 2)
4%
Nausea (grade 2)
4%
Leukopenia (grade 1)
4%
Neutropenia (grade 2)
4%
Elevated CK (grade 4)
4%
Acute enteritis
4%
Elevated AST (grade 4)
4%
Body ache (myalgia) (grade 1)
4%
Joint pain (Arthralgia) (grade 2)
4%
Tooth infection (grade 1)
4%
Conjunctivitis (grade 1)
4%
Presyncope (grade 1)
4%
Elevated ALT AST (grade 1)
4%
Tenderness (grade 2)
4%
Pruritis (grade 2)
4%
Pain (grade 2)
4%
Swelling/Induration (grade 2)
4%
Hypertension (grade 2)
4%
Tenderness (grade 3)
4%
Nausea (grade 1)
4%
Hypertension (grade 1)
4%
Toe infection (grade 1)
4%
URI (grade 1)
4%
Anemia (grade 1)
4%
Severe acute enteritis
4%
Swelling/Induration (grade 1)
100%
80%
60%
40%
20%
0%
Study treatment Arm
IIV Delivered by MN Patch by Subject
IIV Delivered by MN Patch by Study Staff
IIV Delivered IM by Study Staff
Placebo MN Patch by Study Staff

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
2,000 Previous Clinical Trials
42,880,048 Total Patients Enrolled
E. John Wherry, PhDPrincipal InvestigatorUniversity of Pennsyvlania

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

Frequently Asked Questions

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

Are new patients currently being accepted into this clinical trial?

"According to the latest update on clinicaltrials.gov, this particular trial is not looking for patients at this time. The study was originally posted on October 20th, 2017 and was updated as recently as August 22nd, 2022. There are currently 784 other trials that are enrolling participants."

Answered by AI

Is it harmful to receive the Inactivated influenza vaccine?

"Since this is a phase 4 trial and the Inactivated influenza vaccine has been approved, it received a score of 3 for safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Flu Vaccine Responses in the Setting of Melanoma Treatment
2017. "Flu Vaccine Responses in the Setting of Melanoma Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03315975.
~1 spots leftby Jul 2024
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