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

• Status: Completed
• Trial end date: 2017-01-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Benralizumab; Vaccines

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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