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High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant

NCT02860039 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-10-22

Study results available
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Summary

This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.

Conditions

  • Hematopoietic Cell Transplantation Recipient
  • Malignant Neoplasm
  • Influenza

Interventions

BIOLOGICAL

Trivalent Influenza Vaccine

High dose Trivalent Influenza Vaccine given intramuscular

BIOLOGICAL

Quadrivalent Influenza Vaccine

Standard dose Quadrivalent Influenza Vaccine given intramuscular

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Natasha Halasa, MD, MPH · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-12-01
Completion
2024-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02860039 on ClinicalTrials.gov