Flu Vaccine Responses in the Setting of Melanoma Treatment

NCT03315975 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 826207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. We are conducting a prospective unblinded study of influenza vaccine recipients.

Conditions

Viral Vaccines

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Neutralizing antibody response

  The neutralizing antibody titer will be assessed by measurement of the hemagglutinin-inhibition titer before and after influenza vaccination in order to determine the seroconversion rate. The late blood draw may occur between days 21-42 following vaccination.

  21-42 days

Study Arms (1)

Influenza vaccination cohort

EXPERIMENTAL

Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.

Biological: Inactivated influenza vaccine

Interventions

Inactivated influenza vaccine BIOLOGICAL

One dose of quadrivalent inactivated influenza vaccine

Influenza vaccination cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults capable of providing consent
• have a diagnosis of locally advanced or metastatic melanoma

You may not qualify if:

• are allergic to influenza vaccination
• have received influenza vaccination within the past 6 months
• require prednisone, methotrexate, or other immunosuppressing medications
• have HIV infection
• have a history of solid organ or bone marrow transplant
• require combination immunotherapy
• are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• E. John Wherry, PhD

  University of Pennsyvlania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 20, 2017
• Study Start: October 20, 2017
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)