Chronic Obstructive Pulmonary DiseasePhase 4NCT02563184
Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Fluzone in people with Chronic Obstructive Pulmonary Disease, run by Banner Health at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Fluzone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Pulmonary Associates
Phoenix, Arizona, 85006
Sunny Sambhara, MD, 602-258-4951
About this study
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Fluzone
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoneBiological
| Study group | Role | What they receive |
|---|---|---|
| COPD | Active comparator | Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent. Receives: Biological: Fluzone |
| Control | Active comparator | Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent. Receives: Biological: Fluzone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banner Health
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Principal investigator, David Baratz, M.D., Banner Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563184
- Sponsor's protocol ID
- Flu Vaccine Quad vs Tri
- Status last verified
- Sep 2015
- First submitted
- 28 Sep 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02563184
- Acronym / sponsor ID
- Flu Vaccine Quad vs Tri
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Banner HealthUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | Active comparator | Biological: FluzoneGroup will receive either the Fluzone Trivalent or Fluzone Quadrivalent. |
| Control | Active comparator | Biological: FluzoneGroup will receive either the Fluzone Trivalent or Fluzone Quadrivalent. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- Severe allergy to eggs.
- Severe reaction to past doses of influenza vaccine.
- Guillian-Barre syndrome.
- Currently recieving dialysis.
- Current, active, treatment for cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzone | Biological | COPD, Control |
Primary outcome
Hemagglutination inhibiting antibodies (HI) against the components of viral antigens
Time frame: 3 months
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluzone in people with Chronic Obstructive Pulmonary Disease, run by Banner Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemagglutination inhibiting antibodies (HI) against the components of viral antigens (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2015.