Influenza Vaccine Feasibility Study in Children With Persistent Asthma

NCT02967393 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-04-23

Study results available
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Summary

This study is designed to note whether a larger safety study using quadrivalent live attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients in this study will receive the FLUARIX® influenza vaccine, while the other half will receive a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as a surrogate for LAIV4.

Conditions

  • Asthmatic

Interventions

DRUG

ccIIV4

DRUG

IIV4

Sponsors & Collaborators

Principal Investigators

  • Kathryn M Edwards, MD · Vanderbilt Vaccine Research Program

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-10
Primary Completion
2017-02-01
Completion
2017-02-01

Countries

  • United States

Study Locations

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Entities

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 NCT02967393 on ClinicalTrials.gov