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NCT02006784 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Vanderbilt University.

Completed
Registry status
17
Enrollment target

NCT02006784: Completed study, sponsored by Vanderbilt University.

NCT02006784 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02006784 has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
17 participants
Enrollment target

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.

Primary Outcome

* Ability to recruit the entire sample cohort of 30 subjects during the pre-planned enrollment period. * Eighty percent of subjects complete all blood draws within the designated time frame * Adherence to protocol for blood collection, reaction assessment, clinic follow up, and laboratory analysis for 80% of the enrolled cohor

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2013-09
Est. Completion 2017-04
Vanderbilt University

430 total trials

What the finished NCT02006784 record still lists

NCT02006784 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02006784 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02006784 about?

NCT02006784 is a clinical study titled "Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)". 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...

What is the current status of trial NCT02006784?

This trial is currently completed. The enrollment target is 17 participants. The study started on 2013-09. Estimated completion is 2017-04.

Who is sponsoring clinical trial NCT02006784?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02006784, the US trial registry maintained by the National Library of Medicine. NCT02006784 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.