NCT05384288

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
43mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Oct 2022Dec 2029

First Submitted

Initial submission to the registry

May 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

October 7, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

5.2 years

First QC Date

May 17, 2022

Last Update Submit

January 8, 2026

Conditions

Hematologic MalignancyPediatric CancerTransplant-Related Cancer

Keywords

Influenza infection

Outcome Measures

Primary Outcomes (2)

  • Proportion of evaluable participants.

    Feasibility is estimated as the proportion of evaluable patients who provide a baseline and Day +35 sample. A 95% confidence interval will be provided.

    3 years

  • Proportion of participants with immunogenicity 3 to 5 weeks following vaccination.

    Immunogenecity will be measured by the development of cell- and antibody-mediated influenza specific responses 3 to 5 weeks following vaccination. Immunogenicity is estimated as the proportion of evaluable patients whose cell- (as measured by development of any detectable specific T cell responses) and antibody-mediated influenza specific responses (as measured by detectable post vaccination antibody titers) 3 to 5 weeks following vaccination. 95% confidence intervals will be provided.

    3 years

Secondary Outcomes (2)

  • Proportion of participants with an immune response 1 to 2 weeks following vaccination.

    3 years

  • Proportion of participants with durability of immunogenicity at 6 months and 1 year post-vaccination.

    3 years

Study Arms (1)

Pediatric Influenza Vaccine Recipients

Pediatric patients eligible to receive seasonal influenza vaccine.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All participants who meet eligible criteria and consent to enrollment on the study.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Hematologic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ramilo Octavio, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramilo Octavio, MD

CONTACT

866-278-5833referralinfo@stjude.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 20, 2022

Study Start

October 7, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

US(1)