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Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)

NCT02006784 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2017-05-03

No results posted yet for this study

Summary

This is an open label, pilot, observational, prospective study of the safety of inactivated influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted during the 2013-2014 influenza season. The study will test conventional and novel biomarkers to assess disease flare and vaccine response and will also collect self-reported signs/symptoms in reactogenicity diaries during the 14 days after vaccination.

Conditions

  • Systemic Lupus Erythematosus (SLE)

Sponsors & Collaborators

Principal Investigators

  • M. Virginia Pascual, MD · Baylor Research Institute

  • Kathryn M Edwards, MD · Vanderbilt Medical Center

  • Theresa Harrington, MD · Centers for Disease Control and Prevention

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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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 NCT02006784 on ClinicalTrials.gov