A Phase 4 interventional study of Fluzone in Chronic Obstructive Pulmonary Disease, sponsored by Banner Health. Status unknown at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-30.
Sponsored by Banner Health · Phase 4, Interventional, and Treatment
To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of GOLD Stage C and D COPD vs. those patients without COPD.
Primary Objectives:
To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of GOLD Stage C and D COPD (vs. those patients without COPD).
To demonstrate immunogenicity by measuring hemagglutination inhibiting antibodies (HI) against the components of viral antigens using seroconversion (≥4 fold increase over baseline titers) and sero-protection (HI titer of ≥40 against the vaccine components).
Secondary Objective:
To assess the degree of antibody response of COPD patients based on severity of disease as measured by FEV1.
To assess the impact of inhaled corticosteroids on the adaptive immune response after vaccination.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Banner Health is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria for patients with COPD will be:
Inclusion criteria for Healthy participants will be:
Exclusion Criteria:
Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.
Biological: Fluzone
Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.
Biological: Fluzone
Hemagglutination inhibiting antibodies (HI) against the components of viral antigens
The investigators will be measuring hemagglutination inhibiting antibodies (HI) against the components of viral antigens using seroconversion (≥4 fold increase over baseline titers) and sero-protection (HI titer of ≥40 against the vaccine components)
Time frame: 3 months
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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