Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
Status unconfirmed · Phase 4
Conditions studied: Chronic Obstructive Pulmonary Disease
In brief
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.
Key facts
- Study ID
- NCT02563184
- Run by
- Banner Health
- People needed
- 100
- Starts
- 2015-09-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2015-09-30
Who can join
Age: 50 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inclusion criteria for patients with COPD will be:
- Signed informed consent prior to initiation of study-mandated vaccination.
- Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD.
- Patients meeting GOLD Classification of Stage C or Stage D COPD.
- Patients 50 years old - 64 years old.
- Inclusion criteria for Healthy participants will be:
- Signed informed consent prior to initiation of study-mandated vaccination.
- No active symptoms of lung disease.
- FEV1/FVC in the normal range > 70% age predicted value.
- No history of tobacco use/abuse.
- No prior history of alpha-1 antitrypsin deficiency.
- Patients 50 years old - 64 years old.
You may not qualify if…
- Severe allergy to eggs.
- Severe reaction to past doses of influenza vaccine.
- Guillian-Barre syndrome.
- Currently recieving dialysis.
- Current, active, treatment for cancer.
- History of transplant (allograft).
- Dementia or Alzheimer's disease diagnosis.
- Prior diagnosis of HIV or AIDS.
- Moderate to severe pulmonary hypertension.
- Serum AST/ALT > 3x the upper limit of normal.
- Patients with exacerbations or respiratory infection during the 4 weeks preceding the onset of the study.
- Active pregnancy.
- Systemic immunomodulating medications.
Where it is running
- Pulmonary Associates — Phoenix, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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