Actively Recruiting

Age: 0 - 18Years
All Genders
NCT05384288

Response to Influenza Vaccination in Pediatric Oncology Patients

Led by St. Jude Children's Research Hospital · Updated on 2026-01-12

150

Participants Needed

1

Research Sites

373 weeks

Total Duration

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AI-Summary

What this Trial Is About

Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine. Primary Objective * To determine the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. * To describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, in a cohort of pediatric leukemia patients. Secondary Objectives * To describe whether an immune response, as measured by development of cell- and/or antibody-mediated influenza specific responses, is detectable 1-2 weeks following vaccination in a cohort of pediatric leukemia patients. * To describe the durability of immunogenicity by measuring cell - and antibody- mediated influenza specific responses at 6 months and 1 year following vaccination in a cohort of pediatric leukemia patients. Exploratory Objectives * To estimate the clinical effectiveness of influenza vaccine in this cohort by monitoring for the development of clinical diagnosis of influenza in the cohort of enrolled pediatric oncology patients. * To correlate results of immune cell frequency in blood, as measured by complete blood count with differential, with development of an immune response to IIV.

CONDITIONS

Official Title

Response to Influenza Vaccination in Pediatric Oncology Patients

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 18 years old or younger at the time of consent and receiving care at St. Jude Children's Research Hospital
  • Diagnosed with a hematological malignancy
  • Eligible to receive the current seasonal influenza vaccine
Not Eligible

You will not qualify if you...

  • Previously received at least one dose of the current seasonal influenza vaccine

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

R

Ramilo Octavio, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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