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A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.

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ClinicalTrials.gov Identifier: NCT03281876
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

The purpose of this study is to test if the vaccine is working well in COPD patients aged 40 to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather further information on safety and immune response.

In the current study, COPD patients with a history of acute exacerbations will receive 2 doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month vaccination schedule, in addition to standard care.

The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable Haemophilus influenza [NTHi] and Moraxella catarrhalis [Mcat]) will be evaluated at pre-defined timepoints (scheduled study visits).

In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s) will take place for each acute exacerbation of COPD occurring from first vaccination up to study conclusion.


Condition or disease Intervention/treatment Phase
Respiratory Disorders Biological: NTHi Mcat investigational vaccine (GSK3277511A) Biological: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase IIB, randomised, observer-blind, placebo-controlled, multi-centric study with two parallel groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Data will be collected in an observer-blind manner. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity and efficacy) will all be unaware of whether vaccine or placebo was administered. Each study site is responsible for having a blinding plan. To work in an observer-blind manner, vaccine preparation and administration will be done by authorised medical personnel who will not participate in any of the study clinical evaluation assays. Two teams of study personnel will hence be set up:

  • A team of unblinded personnel (responsible for the preparation and the administration of the vaccines)
  • A team of blinded personnel (responsible for the clinical evaluation of the subjects).
Primary Purpose: Prevention
Official Title: An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : February 24, 2020
Estimated Study Completion Date : February 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GSK3277511A Group
Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2) at Day 1 and Day 61.
Biological: NTHi Mcat investigational vaccine (GSK3277511A)
Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.

Placebo Comparator: CONTROL Group
Healthy males and females, 40 to 80 years of age, who received two doses of placebo vaccine at Day 1 and Day 61.
Biological: Placebo
Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.




Primary Outcome Measures :
  1. Rate of moderate and severe AECOPD (any cause)-analysis (87% CI) [ Time Frame: From 1 month post-Dose 2 (at Day 91) up to study end (at Day 451), an average of 1 year. ]

    Efficacy of the investigational vaccine is measured by the rate of moderate and severe AECOPD from 1-month post dose 1 up to study end. The Confidence Intervals (CI)of the incidence rate are computed using the Negative Binomial regression model with number of AECOPD as dependent variable; treatment, age group, GOLD grade, history of exacerbations and country as independent variables and the logarithm of time for follow-up (in years) as an offset variable.

    Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze.


  2. Rate of moderate and severe AECOPD (any cause) -Analysis (95% CI) [ Time Frame: From 1 month post-Dose 2 (at Day 91) up to study end (at Day 451), an average of 1 year. ]

    Efficacy of the investigational vaccine is measured by the rate of moderate and severe AECOPD from 1-month post dose up to study end. The CIs of the incidence rate are computed using the Negative Binomial regression model with number of AECOPD as dependent variable; treatment, age group, GOLD grade, history of exacerbations and country as independent variables and the logarithm of time for follow-up (in years) as an offset variable.

    Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze.



Secondary Outcome Measures :
  1. Number of subjects reporting each solicited local adverse event (AE). [ Time Frame: During the 7-day follow-up period (Days 1 to 7) after each vaccination. ]
    Assessed solicited local symptoms are pain, redness and swelling.

  2. Number of subjects reporting each solicited general AE. [ Time Frame: During the 7-day follow-up period (Days 1 to 7) after each vaccination. ]
    Assessed solicited general symptoms are fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nauseas, vomiting, diarrhoea and/or abdominal pain], headache, myalgia and chills].

  3. Number of subjects reporting any unsolicited adverse event (AE). [ Time Frame: During the 30-day follow-up period (Days 1 to 30) after each vaccination. ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for any solicited symptoms.

  4. Number of subjects reporting any potential immune-mediated diseases (pIMDs). [ Time Frame: From first vaccination (Day 1) up to Study end, at Day 451, an average of 15 months. ]
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  5. Number of subjects with serious adverse events (SAEs). [ Time Frame: From first vaccination (Day 1) up to Study end, at Day 451, an average of 15 months. ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity

  6. Rate of moderate and severe AECOPD in vaccinated and control subjects [ Time Frame: At Month 3, 6 and 9 (observation starting 1 month post-Dose2). ]

    The rates of AECOPD are computed using the Negative Binomial regression model with number of AECOPD as dependent variable; treatment, age group, GOLD grade, history of exacerbations and country as independent variables, with logarithm as link function, and the logarithm of time for follow-up (in years) as an offset variable.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  7. Rate of all AECOPD cases in vaccinated and control subjects [ Time Frame: At Month 3, 6 and 9 (observation starting 1 month post-Dose2). ]
    The Incidence rates of AECOPD are computed using the Negative Binomial regression model with number of AECOPD as dependent variable; treatment, age group, GOLD grade, history of exacerbations and country as independent variables, with logarithm as link function, and the logarithm of time for follow-up (in years) as an offset variable.

  8. Rate of all AECOPD cases, classified by severity. [ Time Frame: At Month 3, 6 and 9 (observation starting 1 month post-Dose2). ]

    The Incidence rates of AECOPD are computed using the Negative Binomial regression model with number of AECOPD as dependent variable; treatment, age group, GOLD grade, history of exacerbations and country as independent variables, with logarithm as link function, and the logarithm of time for follow-up (in years) as an offset variable.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  9. Time to first moderate or severe AECOPD. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    Time to first occurrence of any episode of AECOPD expressed in terms of Person-year rate = number of first episode (n)/ sum of follow-up expressed in years (T[year]).

    Analysis using Cox's proportional hazard regression model with treatment, GOLD grade at enrolment (2, 3 or 4) and history of exacerbations (<2 or ≥ 2) as factors.

    Anthonisen criteria used to detect AECOPD:

    Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze.

    Severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate = requires treatment with systemic corticosteroids and/or antibiotics. Severe = requires hospitalization.


  10. Time to first AECOPD of any severity. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    Time to first occurrence of any episode of AECOPD expressed in terms of Person-year rate = number of first episode (n)/ sum of follow-up expressed in years (T[year]).

    Analysis using Cox's proportional hazard regression model with treatment, GOLD grade at enrolment (2, 3 or 4) and history of exacerbations (<2 or ≥ 2) as factors.

    Anthonisen criteria used to detect AECOPD:

    Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze.

    Severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate = requires treatment with systemic corticosteroids and/or antibiotics. Severe = requires hospitalization.


  11. Time to first AECOPD classified by severity. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    Time to first occurrence of any episode of AECOPD expressed in terms of Person-year rate = number of first episode (n)/ sum of follow-up expressed in years (T[year]).

    Analysis using Cox's proportional hazard regression model with treatment, GOLD grade at enrolment (2, 3 or 4) and history of exacerbations (<2 or ≥ 2) as factors.

    Anthonisen criteria used to detect AECOPD:

    Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze.

    Severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate = requires treatment with systemic corticosteroids and/or antibiotics. Severe = requires hospitalization.


  12. Number of days with moderate and severe AECOPDs. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    The length of each AECOPDs is tabulated and presented via descriptive statistics (mean, Standard Deviation).

    Anthonisen criteria used to detect potential acute exacerbations of COPD (AECOPD) and to determine its stop date:

    Worsening of two or more of the following major symptoms for at least two consecutive days: dyspnoea, sputum volume, sputum purulence (colour), OR Worsening of any major symptom together with any of the following minor symptoms for at least two consecutive days: sore throat, cold (nasal discharge and/or nasal congestion), fever (oral temperature ≥ 37.5°C/) without other cause, increased cough, increased wheeze.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  13. Number of days with AECOPDs of any severity. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    The length of each AECOPDs is tabulated and presented via descriptive statistics (mean, Standard Deviation).

    Anthonisen criteria used to detect potential acute exacerbations of COPD (AECOPD) and to determine its stop date:

    Worsening of two or more of the following major symptoms for at least two consecutive days: dyspnoea, sputum volume, sputum purulence (colour), OR Worsening of any major symptom together with any of the following minor symptoms for at least two consecutive days: sore throat, cold (nasal discharge and/or nasal congestion), fever (oral temperature ≥ 37.5°C) without other cause, increased cough, increased wheeze.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  14. Number of days with AECOPDs classified by severity. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    The length of each AECOPDs is tabulated and presented via descriptive statistics (mean, Standard Deviation).

    Anthonisen criteria used to detect potential acute exacerbations of COPD (AECOPD) and to determine its stop date:

    Worsening of two or more of the following major symptoms for at least two consecutive days: dyspnoea, sputum volume, sputum purulence (colour), OR Worsening of any major symptom together with any of the following minor symptoms for at least two consecutive days: sore throat, cold (nasal discharge and/or nasal congestion), fever (oral temperature ≥ 37.5°C) without other cause, increased cough, increased wheeze.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  15. Rate of Non-Typeable Haemophilus influenzae (NTHi)-associated and/ or Moraxella catarrhalis (Mcat)-associated moderate and severe AECOPD. [ Time Frame: Over a period starting 1 month post-Dose 2 and lasting for 1 year. ]

    Respiratory pathogens NTHi and Mcat will be determined by standard agglutination techniques or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  16. Rate of NTHi-associated and/ or Mcat-associated any severity AECOPD. [ Time Frame: Over a period starting 1 month post-Dose 2 and lasting for 1 year. ]

    Respiratory pathogens NTHi and Mcat will be determined by standard agglutination techniques or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  17. Rate of NTHi-associated and/ or Mcat-associated AECOPD cases, classified by severity. [ Time Frame: Over a period starting 1 month post-Dose 2 and lasting for 1 year. ]

    Respiratory pathogens NTHi and Mcat will be determined by standard agglutination techniques or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  18. Time to first moderate and severe NTHi-associated and/ or Mcat-associated AECOPD. [ Time Frame: Up to Study end, at Day 451, an average of 15 months. ]

    Time to first occurrence of any episode of AECOPD associated to NTHI and/or Mcat expressed in terms of Person-year rate = number of first episode (n)/ sum of follow-up expressed in years (T[year]).

    Respiratory pathogens NTHi and Mcat is determined by standard agglutination techniques or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  19. Time to first NTHi-associated and/or Mcat-associated AECOPD of any severity. [ Time Frame: Up to Study end, at Day 451, an average of 15 months. ]

    Time to first occurrence of any episode of AECOPD associated to NTHI and/or Mcat expressed in terms of Person-year rate = number of first episode (n)/ sum of follow-up expressed in years (T[year]).

    Respiratory pathogens NTHi and Mcat will be determined by standard agglutination techniques or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  20. Time to first NTHi-associated and/or Mcat-associated AECOPD, classified by severity. [ Time Frame: Up to Study end, at Day 451, an average of 15 months. ]

    Time to first occurrence of any episode of AECOPD associated to NTHI and/or Mcat expressed in terms of Person-year rate = number of first episode (n)/ sum of follow-up expressed in years (T[year]).

    Respiratory pathogens NTHi and Mcat will be determined by standard agglutination techniques or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  21. Number of days with moderate and severe NTHi-associated and Mcat-associated AECOPD. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    The length of each NTHi associated and/or Mcat associated AECOPDs is tabulated and presented via descriptive statistics (mean, Standard Deviation) Respiratory pathogens NTHi and Mcat will be determined by standard agglutination techniques or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  22. Number of days with NTHi-associated and/or Mcat-associated AECOPDs of any severity. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    The length of each NTHi associated and/or Mcat associated AECOPDs is tabulated and presented via descriptive statistics (mean, Standard Deviation) Respiratory pathogens NTHi and Mcat will be determined by standard agglutination techniques or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  23. Number of days with NTHi-associated and/or Mcat-associated AECOPD, classified by severity. [ Time Frame: During the entire study period (From Day 1 to Day 451), an average of 15 months. ]

    The length of each NTHi associated and/or Mcat associated AECOPDs is tabulated and presented via descriptive statistics (mean, Standard Deviation) Respiratory pathogens NTHi and Mcat will be determined by standard agglutination tools or molecular tools in sputum samples.

    The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization.


  24. Anti-PD, anti-PE, anti-PilA and anti-UspA2 total Immunoglobulin G (IgG) antibody concentrations as measured by the Ezyme-Linked Immunosorbent Assay (ELISA,) in all subjects. [ Time Frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451. ]

    For anti-PD antibodies, the technical cut-off of the assay is 153 ELISA Units per millilitre (EU/mL.).

    For Anti-PE antibodies, the technical cut-off of the assay is 25 EU/mL. For Anti-PilA antibodies, the technical cut-off of the assay is 16 EU/mL. For Anti-UspA2 antibodies, the technical cut-off of the assay is 38 EU/mL. The inconsistency between the changed cut-off values for anti-PE, anti-PilA and anti-UspA2 ELISA assays in Amendment 1 and the cut-off values mentioned in Appendix A (laboratory assays) was corrected in the Administrative Change.


  25. Frequency of specific cluster of differentiation (CD)4+ T-cells immune response for NTHi-specific and Mcat- specific measured by flow cytometry intracellular cytokine staining (ICS) in a sub-cohort of subjects. [ Time Frame: At Day 1, Day 91, Day 271 and at Day 451. ]
    The ICS staining assay is used to assess cell-mediated immunogenicity (CMI) responses. After Peripheral blood mononuclear cell (PBMC) stimulation with the relevant antigens, the frequency of CD4+ T-cells expressing selected set of cytokines such as interleukine-2, 3, 17 (IL-2, IL-13, IL-17), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L) or selected combination of cytokines are evaluated by flow cytometry.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • 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 with forced expiratory volume in 1 second (FEV1) over forced vital capacity (FVC) ratio (FEV1/FVC) < 0.7, AND FEV1 < 80% predicted (GOLD 2, 3 and 4).
  • 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 AECOPD within the 12 months before Screening.

    • Patient for whom the last episode of AECOPD is resolved for at least 30 days at the time of first vaccination.

      • A documented history of a COPD exacerbation is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence. Subject verbal reports are not acceptable.
  • Capable of complying 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. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
  • 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:

  • Use of any investigational or non-registered product 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.
  • 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.
  • Chronic administration 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 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. 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 α-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, clinically significant lung fibrosis, clinically significant pulmonary embolism, clinically significant 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. If the subject has any condition on the non-exhaustive list of potential immune-mediated diseases defined in the protocol, they must be excluded unless the aetiology is clearly documented to be non-immune mediated.
  • Previous vaccination with any vaccine containing NTHi and/ or Mcat antigens.
  • 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.
  • Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded:

Myocardial infarction or unstable angina in the last 6 months. Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months NYHA Class IV Heart failure

  • Malignancies within the previous 5 years or lymphoproliferative disorder.
  • Any known disease or condition likely to cause death during the study period.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281876


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03281876     History of Changes
Other Study ID Numbers: 207489
2017-000880-34 ( EudraCT Number )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Immunogenicity
Vaccination
Chronic Obstructive Pulmonary Disease
Non-typeable Haemophilus influenzae
Acute exacerbation of COPD
Moraxella catarrhalis
Efficacy
Safety

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs