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OpenTrials
Active, Not Recruiting

NCT Number: NCT03315975

Flu Vaccine Responses in the Setting of Melanoma Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Viral Vaccines Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following influenza vaccination have not been studied in the setting of advanced melanoma and in the context of various anti-tumor treatments. In this study, we will look at the immune response of subjects receiving vaccination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Inactivated Influenza Vaccine

Biological

One dose of quadrivalent inactivated influenza vaccine

Primary outcomes

  1. Neutralizing antibody response

    Time frame: 21-42 days

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Influenza Vaccine Responses in the Setting of Melanoma Treatment

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2017
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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