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

Sponsored by Banner Health

About this trial

Last updated 10 years ago

Study ID

Flu Vaccine Quad vs Tri

Status

Unknown status

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
50 to 64 Years
All
All

Trial Timing

Ended 9 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

Inclusion criteria for patients with COPD will be: 1. Signed informed consent prior to initiation of study-mandated vaccination. 2. Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD. 3. Patients meeting GOLD Classification of Stage C or Stage D COPD. 4. Patients 50 years old - 64 years old. Inclusion criteria for Healthy participants will be: 1. Signed informed consent prior to initiation of study-mandated vaccination. 2. No active symptoms of lung disease. 3. FEV1/FVC in the normal range > 70% age predicted value. 4. No history of tobacco use/abuse. 5. No prior history of alpha-1 antitrypsin deficiency. 6. Patients 50 years old - 64 years old.

No

Exclusion Criteria

1. Severe allergy to eggs. 2. Severe reaction to past doses of influenza vaccine. 3. Guillian-Barre syndrome. 4. Currently recieving dialysis. 5. Current, active, treatment for cancer. 6. History of transplant (allograft). 7. Dementia or Alzheimer's disease diagnosis. 8. Prior diagnosis of HIV or AIDS. 9. Moderate to severe pulmonary hypertension. 10. Serum AST/ALT > 3x the upper limit of normal. 11. Patients with exacerbations or respiratory infection during the 4 weeks preceding the onset of the study. 12. Active pregnancy. 13. Systemic immunomodulating medications.

Locations

Location

Status

Recruiting