CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
High-dose trivalent inactivated influenza vaccine +1 moredrug
Likely dose
High-dose trivalent inactivated influenza vaccine 0.5 mLfrom 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/NCT01216332
NCT01216332Phase 1Completed

Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia

Vanderbilt University·interventional·Posted Oct 7, 2010·Updated May 3, 2019

In Brief

A Phase 1 clinical trial evaluating High-dose trivalent inactivated influenza vaccine and Standard dose trivalent inactivated influenza vaccine for Pediatric Patients With Acute Lymphoblastic Leukemia. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.7 years ago

Interventions

High-dose trivalent inactivated influenza vaccinedrug

0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.

Standard dose trivalent inactivated influenza vaccinedrug

0.5 mL standard dose trivalent inactivated influenza vaccine