Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
GlaxoSmithKline S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. electronic Diary Card completion, number of blood draws, sputum sampling, pre- and post-bronchodilator spirometry, return for follow-up visits). • Written informed consent obtained from the subject prior to performing any study specific procedure. • A male or female between, and including, 40 and 80 years of age at the time of the first vaccination. • Confirmed diagnosis of COPD (based on post-bronchodilator spirometry) with forced expiratory volume in 1 second (FEV1) over forced vital capacity (FVC) ratio (FEV1/FVC) =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period. • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. • 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. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • 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. • 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 (pharmaceutical product or device). • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose (e.g. methotrexate). • Administration of systemic corticosteroids (prednisone =10 mg/day, or equivalent) within the 30 days before first vaccination. - Subjects who received systemic corticosteroids within this period may be enrolled at a later date if enrolment is still open. - Inhaled and topical steroids are allowed. • Administration of systemic antibiotics within the 30 days before first vaccination. - Subjects who received systemic antibiotics within this period may be enrolled at a later date if enrolment is still open. • Chronic use of antibiotics for prevention of AECOPD (e.g. azithromycin). • Acute disease and/or fever at the time of first vaccination. - Fever is defined as temperature >=37.5°C/99.5°F. The preferred location for measuring temperature in this study will be the oral cavity or the axilla. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. • Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3L/min (Oxygen use =3L/min flow is not exclusionary). • Planned lung transplantation. • Lung resection: Subjects with planned lung volume reduction surgery during the study or within the 12 months prior to first vaccination. • Diagnosis of a-1 antitrypsin deficiency as the underlying cause of COPD. • Diagnosed with a respiratory disorder other than COPD at time of enrolment (such as sarcoidosis, active tuberculosis, clinically significant bronchiectasis, lung fibrosis, pulmonary embolism, pneumothorax, current diagnosis of asthma in the opinion of the investigator), 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 do not need to be excluded and may be enrolled at the discretion of the investigator. • History of immune-mediated disease other than COPD. • Previous vaccination with any vaccine containing NTHi and/ or Mcat antigens. • History of any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe acute exacerbations of COPD (AECOPDs).;Secondary Objective: • To describe the safety and reactogenicity of the investigational vaccine. • To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of all AECOPDs and by severity (i.e. mild, moderate or severe). • To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of all AECOPDs and by severity (i.e. mild, moderate or severe) associated with NTHi and/or Mcat detected by polymerase chain reaction (PCR). • To evaluate the humoral immunogenicity of the investigational vaccine. • To evaluate the cellular immunogenicity of the investigational vaccine.;Primary end point(s): Rate of moderate and severe AECOPD (any cause);Timepoint(s) of evaluation of this end point: From 1 month post-Dose 2 up to study end at Day 451. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1) and 2) During the 7-day follow-up period (Days 1-7) after each vac-cination 3) During the 30-day follow-up period (Days 1-30) after each vaccination. 4) and 5) From first vaccination (Day 1) up to Study end, at Day 451. 6), 7) and 8) During 3, 6 and 9 months observation starting 1 month post-Dose 2. 9), 10), 11), 12), 13), 14), 18), 19), 20), 21), 22) and 23) Up to Study end, at Day 451. 15), 16) and 17) Over a period starting 1 month post-Dose 2 and lasting for 1 year. 24) at Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451 25) at Day 1, Day 91, Day 271 and at Day 451;Secondary end point(s): 1) Occurrence of each solicited local adverse event (AE). 2) Occurrence of each solicited general AE. 3) Occurrence of any unsolicited AE. 4) Occurrence of any potential immune-mediated disease (pIMD). 5) Occurrence of any serious adverse event (SAE). 6) Incidence rate of moderate and severe AECOPD cases in vaccinated and control subjects. 7) Incidence rate of all AECOPD cases in vaccinated and control subjects. 8) Incidence rate of all AECOPD cases in vaccinated and control subjects by severity. 9) Time to first moderate or severe AECOPD. 10) Time to first AECOPD of any severity. 11) Time to first AECOPD, by severity. 12) Duration of moderate and severe AECOPDs. 13) Duration of AECOPDs of any severity. 14) Duration of AECOPDs, by severity. 15) Rate of NTHi-associated and/ or Mcat-associated moderate and severe AECOPD. 16) Rate of NTHi-associated and/ or Mcat-associated any severity AECOPD. 17) Rate of NTHi-associated and/ or Mcat-associated AECOPD, by severity. 18) Time to first moderate or severe NTHi-associated and/ or Mcat-associated AECOPD. 19) Time to first NTHi-associated and/or Mcat-associated AECOPD of any severity. 20) Time to first NTHi-associated and/or Mcat-associated AECOPD, by severity. 21) Duration of moderate and severe NTHi-associated and Mcat-associated AECOPD. 22) Duration of NTHi-associated and/or | — |
Countries
Belgium, Canada, France, Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactCentro de Información
GlaxoSmithKline S.A.
Outcome results
None listed