CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Fluzone High Dose +1 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/NCT01685372
NCT01685372Phase 2Completed
CompareCT.gov

Immunogenicity and Efficacy of High-dose Trivalent Inactivated Seasonal Influenza Vaccine (Fluzone High Dose) in Immunocompromised Children and Young Adults.

University of Colorado, Denver·interventional·Posted Sep 14, 2012·Updated Jan 23, 2018

In Brief

A Phase 2 clinical trial evaluating Fluzone High Dose and Fluzone for Solid Organ Transplant Recipient (Liver, Kidney, Heart) and 4 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Organ Transplant Recipient (Liver, Kidney, Heart), Rheumatologic Disorder, Human Immunodeficiency Virus (HIV), Bone Marrow Transplant (BMT), Dialysis
CountriesUnited States
CollaboratorsColorado Clinical & Translational Sciences Institute

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2012
Enrollment StartSep 1, 2012
Primary CompletionSep 1, 2015
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.8 years ago

Interventions

Fluzone High Dosebiological

A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm

Fluzonebiological

A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm