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Responses to Influenza Vaccine in Patients With Mitochondrial Disorders (MELAS)

NCT01831934 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-05-30

Study results available
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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.

Conditions

  • MELAS Syndrome

Interventions

BIOLOGICAL

Fluzone®

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Cornelia L Dekker, MD · Stanford University

  • Gregory M Enns, MBChB · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-12-31
Completion
2012-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01831934 on ClinicalTrials.gov