CClinicalTrials.gg
Status unknownNCT02563184Updated Sep 30, 2015

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

A Phase 4 interventional study of Fluzone in Chronic Obstructive Pulmonary Disease, sponsored by Banner Health. Status unknown at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-30.

Sponsored by Banner Health · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
50 Years to 64 Years
Sex
All
01

Study 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.

Read the detailed description

Primary Objectives:

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).

To demonstrate immunogenicity by 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).

Secondary Objective:

To assess the degree of antibody response of COPD patients based on severity of disease as measured by FEV1.

To assess the impact of inhaled corticosteroids on the adaptive immune response after vaccination.

02

Conditions studied

03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 100 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Banner Health is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    COPD

    Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

    Biological: Fluzone

  • Active comparator
    Control

    Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

    Biological: Fluzone

Interventions

  • BiologicalFluzone
06

What researchers measure

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)

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Pulmonary Associates
    Phoenix, Arizona 85006, United States
    • Sunny Sambhara, MD · Contact · 602-258-4951
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02563184
Lead sponsor
Banner Health
Collaborators
Sanofi Pasteur, a Sanofi Company
Responsible party
David Baratz, M.D. (Medical Doctor, Banner Health) — Principal investigator
First posted
Sep 30, 2015
Start date
Sep 2015
Primary completion
Dec 2015 (estimated)
Completion
Feb 2016 (estimated)
Last update
Sep 30, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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