Recruiting

Quadrivalent vs. Trivalent

Sponsor:

Banner Health

Code:

NCT02563184

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 50 - 64

Healthy Volunteers: Accepted

Interventions

Fluzone

Study Details

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT02563184

Start date

Sep, 2015

Status verified date

Sep, 2015

Completion date

Feb, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 64

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: COPD

Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

active comparator: Control

Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

Interventions

Fluzone

Primary outcome measure

  • Hemagglutination inhibiting antibodies (HI) against the components of viral antigens [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Pulmonary Associates

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Sunny Sambhara, MD

602-258-4951

More Information

Sponsor

Banner Health

Last update posted

Sep 30, 2015

Last verified

Sep, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Banner Health on 2015-09-30.