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NCT05384288 · ClinicalTrials.gov registry record
Response to Influenza Vaccination in Pediatric Oncology Patients
A clinical trial of Pediatric Cancer and Hematologic Malignancy, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT05384288: Recruiting study of Pediatric Cancer and Hematologic Malignancy, sponsored by St. Jude Children's Research Hospital.
NCT05384288 is a study of Pediatric Cancer and Hematologic Malignancy that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 150 participants, below the 1,488-participant average among 51 other Pediatric Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05384288, a study of Pediatric Cancer and Hematologic Malignancy, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Feasibility is estimated as the proportion of evaluable patients who provide a baseline and Day +35 sample. A 95% confidence interval will be provided.
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-10-07 |
| Est. Completion | 2029-12-01 |
What NCT05384288 shows while recruiting
NCT05384288 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,488-participant average among 51 other Pediatric Cancer trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Pediatric Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT05384288 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05384288 about?
NCT05384288 is a clinical study titled "Response to Influenza Vaccination in Pediatric Oncology Patients". 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...
What is the current status of trial NCT05384288?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2022-10-07. Estimated completion is 2029-12-01.
What conditions does trial NCT05384288 study?
This clinical trial studies the following conditions: Pediatric Cancer, Hematologic Malignancy, Transplant-Related Cancer.
Who is sponsoring clinical trial NCT05384288?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05384288 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05384288's enrollment target sits among peer trials
150 17th of 51 higher than 33 of 51 other Pediatric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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