NCT02563184

Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Banner Health · Academic / Other
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2015-09-30
• Last updated: 2015-09-30

Locations

1 site across 1 country: United States