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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

NCT02814643 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-10-24

Study results available
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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

Conditions

Interventions

DRUG

Benralizumab

Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 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.

Sponsors & Collaborators

Principal Investigators

  • Pamela L Zeitlin, M.D. Ph.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2017-01-24
Completion
2017-01-24

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02814643 on ClinicalTrials.gov