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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 9 years ago
What is this trial about?
What are the participation requirements?
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.
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.