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Response to Influenza Vaccination in Pediatric Oncology Patients

NCT05384288 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-01-12

No results posted yet for this study

Summary

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

  • Hematologic Malignancy
  • Pediatric Cancer
  • Transplant-Related Cancer

Sponsors & Collaborators

Principal Investigators

  • Ramilo Octavio, MD · St. Jude Children's Research Hospital

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-07
Primary Completion
2027-12-01
Completion
2029-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384288 on ClinicalTrials.gov