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

NCT02563184 | Unknown Phase 4

• 1 other identifier: Flu Vaccine Quad vs Tri
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hemagglutination inhibiting antibodies (HI) against the components of viral antigens

  The investigators will be 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)

  3 months

Study Arms (2)

COPD

ACTIVE COMPARATOR

Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

Biological: Fluzone

Control

ACTIVE COMPARATOR

Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

Biological: Fluzone

Interventions

Fluzone BIOLOGICAL

COPD; Control

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Banner Health: lead
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

Pulmonary Associates

Phoenix, Arizona, 85006, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 30, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

US (1)