Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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