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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination

Key facts

Study ID

NCT02814643

Run by

AstraZeneca

People needed

103

Starts

2016-07-01

Expected to finish

2017-01-24

Last updated by the study team

2018-10-24

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1
• 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

You may not qualify if…

• Clinically important pulmonary disease other than asthma
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.