A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction.
Condition: Respiratory Disorders
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders; Respiratory Tract Diseases
Intervention: NTHi-10-AS01E; NaCl Placebo
Intervention description: Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Immunogenicity; Observer-blind; Reactogenicity; Chronic Obstructive Pulmonary Disease; Safety

Summary:

      The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity
      of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with
      moderate and severe persistent airflow obstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  A male or female between, and including, 40 and 80 years of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the subject.

          -  Confirmed diagnosis of COPD with forced expiratory volume in 1 second (FEV1) over
             forced vital capacity (FVC) ratio (FEV1/FVC) < 0.7, AND FEV1 < 80% and ≥ 30%
             predicted.

          -  Current or former smoker with a cigarette smoking history of ≥ 10 pack-years.

          -  Stable COPD patient with documented history of at least 1 moderate or severe acute
             exacerbation of COPD within the 12 months before Screening.

          -  Regular sputum producer.

          -  Capable to comply with the daily electronic Diary Card completion throughout the study
             period, according to investigator's judgement at Visit 1.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the vaccination series.

        Exclusion Criteria:

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational vaccine/ product.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before the first dose and ending 30 days after the last
             dose of vaccine, with the exception of any influenza or pneumococcal vaccine which may
             be administered ≥ 15 days preceding or following any study vaccine dose.

          -  Previous vaccination with any vaccine containing NTHi antigens.

          -  Administration of immunoglobulins or any blood products within the 3 months preceding
             the first dose of study vaccine or planned administration during the study period.

          -  Chronic administration of non-steroid immunosuppressants or other immune-modifying
             drugs within 6 months prior to the first vaccine dose.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of immune-mediated disease other than COPD.

          -  Administration of systemic corticosteroids within the 30 days before Screening.

          -  Administration of systemic antibiotics within the 30 days before Screening.

          -  Chronic use of antibiotics for prevention of acute exacerbations of COPD (AECOPD).

          -  Receiving oxygen therapy.

          -  Planned lung transplantation.

          -  Planned/ underwent lung resection surgery.

          -  Diagnosis of α-1 antitrypsin deficiency as the underlying cause of COPD.

          -  Diagnosed with a respiratory disorder other than COPD, or chest X-ray/ CT scan
             revealing evidence of clinically significant abnormalities not believed to be due to
             the presence of COPD. Subjects with allergic rhinitis can be enrolled.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines and/ or the bronchodilator used for spirometry assessment during the
             study.

          -  Contraindication for spirometry testing.

          -  Clinically significant abnormality in haematology or biochemistry parameter.

          -  Acute cardiac insufficiency.

          -  Malignancies within the previous 5 years or lymphoproliferative disorder.

          -  Any known disease or condition likely to cause death during the study period.

          -  Acute disease and/ or fever at the time of Screening.

               -  Fever is defined as oral or axillary temperature ≥ 37.5°C. The preferred route
                  for recording temperature in this study will be oral.

               -  Subjects with acute disease and/ or fever at the time of Screening may be
                  enrolled at a later date if enrolment is still open. Subjects with a minor
                  illness without fever may be enrolled at the discretion of the investigator.

          -  Pregnant or lactating female.

          -  Current alcoholism and/or drug abuse.

          -  Other condition which the investigator judges may put the safety of the subject at
             risk through study participation or which may interfere with the study findings.

          -  Planned move to a location that will complicate participation in the trial through
             study end.