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 - ALIZE
Study identifier:D3250C00033
ClinicalTrials.gov identifier:NCT02814643
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b 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.
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Benralizumab, Benralizumab Placebo, Seasonal influenza virus vaccine
Sex
All
Actual Enrollment
103
Study type
Interventional
Age
12 Years - 21 Years
Date
Study Start Date: 01 Jul 2016
Primary Completion Date: 24 Jan 2017
Study Completion Date: 24 Jan 2017
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Supportive Care
Verification:
Verified 01 Oct 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 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. | Drug: Benralizumab Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Drug: Seasonal influenza virus vaccine Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8. |
| Placebo Comparator: 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. | Drug: Benralizumab Placebo Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Drug: Seasonal influenza virus vaccine Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8. |
Contacts
Investigators
Principal Investigator
Pamela L Zeitlin
The Johns Hopkins Hospital
