MedDataX Logo

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

NCT ID: NCT02563184

Last Updated: 2015-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD

Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

Group Type ACTIVE_COMPARATOR

Fluzone

Intervention Type BIOLOGICAL

Control

Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

Group Type ACTIVE_COMPARATOR

Fluzone

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluzone

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.


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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Banner Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Baratz, M.D.

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pulmonary Associates

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sunny Sambhara, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Flu Vaccine Quad vs Tri

Identifier Type: -

Identifier Source: org_study_id