CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Trivalent Influenza Vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02860039
NCT02860039Phase 2Completed
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Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients

Vanderbilt-Ingram Cancer Center·interventional·Posted Aug 9, 2016·Updated Oct 22, 2024

In Brief

A Phase 2 clinical trial evaluating Trivalent Influenza Vaccine, Quadrivalent Influenza Vaccine, and 1 other intervention for Hematopoietic Cell Transplantation Recipient and 2 related conditions. Completed, enrolled 170 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematopoietic Cell Transplantation Recipient, Malignant Neoplasm, Influenza
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 9, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 1, 2021
Study CompletionSep 1, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.9 years ago

Interventions

Trivalent Influenza Vaccinebiological

High dose Trivalent Influenza Vaccine given intramuscular

Quadrivalent Influenza Vaccinebiological

Standard dose Quadrivalent Influenza Vaccine given intramuscular

Laboratory Biomarker Analysisother

Correlative studies