CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Fluzone®biological
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/NCT01831934
NCT01831934Phase 4Completed
CompareCT.gov

Metabolic and Immune Responses to TIV in Patients With Mitochondrial Disease

Stanford University·interventional·Posted Apr 15, 2013·Updated May 30, 2017

In Brief

A Phase 4 clinical trial evaluating Fluzone® for MELAS Syndrome. Completed, enrolled 22 participants across 1 site.

Detailed Summary

This pilot clinical study evaluated the safety and metabolic responses to a licensed inactivated seasonal influenza vaccine (TIV) in mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes syndrome (MELAS) volunteers and controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMELAS Syndrome
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2013
Enrollment StartSep 1, 2010
Primary CompletionDec 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.2 years ago

Interventions

Fluzone®biological

This vaccine is given intramuscularly, either the 2010-2011 or 2011-2012 vaccination was given as appropriate