Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT05384288

Conditions

Hematologic Malignancy

Pediatric Cancer

Transplant-Related Cancer

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT05384288

Start date

Oct 7, 2022

Status verified date

Jun, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient ≤ 18 years old at the time of consent receiving care at St. Jude Children's Research Hospital
  • Diagnosed with a hematological malignancy
  • Eligible to receive the current seasonal influenza vaccine

Exclusion Criteria:

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric Influenza Vaccine Recipients

Pediatric patients eligible to receive seasonal influenza vaccine.

Primary outcome measure

  • Proportion of evaluable participants. [ Time Frame: 3 years ]
  • Proportion of participants with immunogenicity 3 to 5 weeks following vaccination. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Ramilo Octavio, MD

866-278-5833referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Ravilo Octavio, MD

866-278-5833referralinfo@stjude.org

Principal Investigator:

Ramilo Octavio, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Influenza infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-12.