Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma
NCT ID: NCT02814643
Last Updated: 2018-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2016-07-01
2017-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Benralizumab
1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Benralizumab
Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
Seasonal influenza virus vaccine
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Placebo
1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Benralizumab Placebo
Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
Seasonal influenza virus vaccine
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Interventions
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Benralizumab
Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
Benralizumab Placebo
Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
Seasonal influenza virus vaccine
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Eligibility Criteria
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Inclusion Criteria
* Weight of ≥40 kg
* Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA)
* Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of \>50% predicted at Visit 1 or Visit 2.
* Airway reversibility (FEV1 \>12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR
* Airway reversibility documented in the previous 12 months prior to Visit 1
* An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR
* Any condition assessed by patient recall over the previous 2-4 weeks
Exclusion Criteria
* Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine
* Receipt of an influenza vaccine within 90 days prior to randomization
* Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma
* Acute illness or evidence of significant active infection or known influenza infection during the current flu season
12 Years
21 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Pamela L Zeitlin, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Mesa, Arizona, United States
Research Site
Huntington Beach, California, United States
Research Site
Newport Beach, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Denver, Colorado, United States
Research Site
Aventura, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Bellevue, Nebraska, United States
Research Site
Northfield, New Jersey, United States
Research Site
Edmond, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Medford, Oregon, United States
Research Site
North Charleston, South Carolina, United States
Research Site
Arlington, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
New Braunfels, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Waco, Texas, United States
Research Site
Clinton, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D3250C00033
Identifier Type: -
Identifier Source: org_study_id
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