Asthma, Chronic Obstructive Pulmonary Disease, Pneumococcal Infections
Conditions
Keywords
Pneumococcal vaccines
Brief summary
Goal: to to examine the formation of postvaccination immunity and evaluate the therapeutic effect of bacterial vaccines in patients with inflammation diseases of bronchopulmonary system. Objectives of the study: assessment of microbiocenosis mucous membranes of the upper respiratory tract in patients with bronchopulmonary pathology before and after use of bacterial vaccines. Identification of mayor lymphocytes subpopulations in patients in the dynamics of the vaccination process. Study the profile of humoral immune response in patients under different schemes of vaccination. Assessment of the clinic and functional status bronchopulmonary system in the immunized patients.
Detailed description
Methods: 1. Immunoglobulin G (IgG)-antibodies against Streptococcus pneumoniae (S. pneumoniae) - solid-phase enzyme-linked immunoelectrodiffusion essay (ELISA). 2. General levels of Immunoglobulin A (IgA), Immunoglobulin M (IgM), IgG, Immunoglobulin E (IgE) in sera - radial immunodiffusion. 3. Phagocytic activity (granulocytes, monocytes), nitroblue tetrazolium test; T-lymphocytes, T-helpers (cluster of differentiation, CD3+CD4+), cytotoxic T-lymphocytes (СD3+CD8+), B-lymphocytes (CD19+); NK-cells (CD3-CD16+CD56+), NKT-cells (CD3+CD16+CD56+), activated T-cells (human leucocyte antigens, CD3+HLA DR+), CD3-HLA DR+. 4. Microbiological examination of sputum. 5. Determining the clinical effectiveness of vaccination. * the number of exacerbations of chronic bronchopulmonary pathology for the year prior to vaccination and during the first and fourth years after vaccination; * the number of courses of antibiotic therapy a year prior to vaccination and during the first and fourth years after immunization; * the number of hospitalizations for acute exacerbations of chronic bronchopulmonary disease during the year prior to vaccination and during the first and fourth years after immunization. 6. Method of estimating quality of life associated with health in patients with chronic bronchopulmonary pathology (asthma control questionnaire (ACQ-5), COPD assessment test (CAT)). Characteristics of variables (arms 1-8). 1. The age of patients (years): mean (standard deviation) \[min; median; max\] for normally distributed variables; median \[Q25; Q75\] - for variables with distribution different from normal. 2. Gender: male/female. 3. Indicators of immune status * IgG antibodies to S. pneumoniae * IgA, g/l \[0,4-3,5\] * IgM, g/l \[0,7-2,8\] * IgG, g/l \[8-18\] * IgE, IU/ml \[\< 100\] * Phagocytic index (granulocyte), % \[82-90\] * Phagocytic index (monocytes), % \[75-85\] * The participation rate of spontaneous NBT-test (neutrophils), % with intensity of 0.2.e. \[7-14\] * The index of activity induced NBT-test (neutrophils), % if intensity \>of 0.36.e. \[\>28\] * The percentage of NBT-positive cells in spontaneous test, % \[2-19\] * Circulating immune complexes (CEC) cond. units \[0,055-0,11\] * CD3+, % \[55-80\] * CD3+CD4+, % \[31-49\] * CD3+CD8+, % \[12-30\] * CD19+, % \[5-19\] * CD3-CD16+CD56+, % \[6-20\] * CD3+CD16+CD56+, % \[\<10\] * CD3-HLA DR+, % \[5-20\] * CD3+HLA DR+, % \[\<12\] * CD45RO. The reference value = 0,2. 4. Microbiological examination of sputum: frequency of selection of certain microorganisms are presented as absolute number of cases and % in the respective groups. 5. Evaluation of early post-vaccination period * The General condition (satisfactory/unsatisfactory) * Local reactions: pain (n/%), redness (n/%, cm), consolidation (n/%, cm) * General reactions: * Temperature 37,0-37,5 (n/%) * Temperature of 37.6-38,5 (n/%) * A temperature of 38.6 and \> (n/%) * Headache (n/%) * Malaise, fatigue (n/%) * Joint pain (n/%) * Muscle pain (n/%) 6. Health related quality of life (HRQoL): CAT-test (for Chronic obstructive pulmonary disease (COPD) patients), ACQ-5 (for asthma patients).
Interventions
BIOLOGICALPrevenar-13
Conjugate 13 serotype pneumococcal vaccine
BIOLOGICALPneumo-23
Polysaccharide 23-valent pneumococcal vaccine.
Sponsors
Pfizer
Mikhael Petrovich Kostinov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Individuals of both sexes from 18 years with a diagnosis of COPD or Bronchial Asthma; * The presence of signed and dated informed consent to participate in a clinical study; * The ability to perform the requirements of the Protocol; * For women of childbearing age is a negative result of a pregnancy test before vaccination. Diagnostic criteria for: \- COPD: dyspnea: progressive (worsens over time), increases with exertion, persistent; chronic cough (may appear sporadically and may be unproductive); chronic expectoration; the impact of risk factors in the medical history (Smoking, occupational dust pollutants and chemicals); widespread wheeze on auscultation of the chest and/or distant wheezing in the chest; family history of COPD; spirometric data confirming the presence of fixed bronchial obstruction.
Exclusion criteria
* Vaccination against pneumococcal infection in anamnesis; * Application of preparations of immune globulin or blood transfusion within last three months prior to clinical studies; * Prolonged use (more than 14 days) immunosuppressants or other immunosuppressive drugs within 6 months prior to the start of the study; * Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection; * A history or currently hematologic and other cancers; * A positive reaction for HIV infection, viral hepatitis B and hepatitis C; * The presence of respiratory, cardio-vascular insufficiency, impaired liver and kidney function, established during a physical examination at visit number 1; * Pronounced congenital defects or serious chronic diseases in the acute stage, including any clinically important exacerbation of chronic diseases of the liver, kidney, cardiovascular, nervous system, mental diseases or metabolic disorders, confirmed by the history or objective examination (pulmonary: cystic fibrosis, lung abscess, empyema, active tuberculosis; extra-pulmonary: congestive heart failure, malabsorption, chronic renal and hepatic failure, cirrhosis, malignancy, immunodeficiency, cirrhosis of the liver); * Severe allergic reactions in anamnesis, autoimmune disease; * The presence of acute infectious and/or communicable illnesses within 1 month prior to study; * History of chronic alcohol abuse and/or drug use; * Exacerbation of chronic diseases; * Breastfeeding; * Pregnancy; * Participation in any other clinical study within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination | Number of patients without exacerbations of the underlying disease, antibiotic use and hospitalisation. |
| The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination | The number of exacerbations of the underlying disease, antibiotic use and hospitalisation. The average number of exacerbations per 1 patient = total exacerbations in the group / number of patients in the group. This is not a mean value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination | Phagocytic index (granulocytes), phagocytic index (monocytes), activity of a spontaneous HCT test (neutrophils), activity of an induced HCT test (neutrophils), percentage of HCT-positive white blood cells in a spontaneous test. The phagocytic index was calculated according to the following formula: phagocytic index = (total number of engulfed cells/total number of counted macrophages) × (number of macrophages containing engulfed cells/total number of counted macrophages) × 100 (phagocytic index) The phagocytic index was calculated by counting at least 100 bacteria phagocytized by certain number of phagocytic cells/macrophages and expressed following formula (Mamnur Rashid 1997): Phagocytic index = Total no. of phagocytized bacteria /No of phagocytic cells phagocytizing bacteria. Activation index = % formazan positive cells (FPC) in NBT stimulated / % formazan positive cells (FPC) in NBT Spontaneous. |
| Immunophenotype of Blood Lymphocytes in Patients With COPD | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination | Immunophenotype of blood lymphocytes in patients with COPD at baseline, 1, 2 and 6 weeks after PCV13 and PPV23 vaccination. It was pre-specified to report data from only the COPD - Prevenar-13 and the COPD - Pneumo-23 Arms/Groups for this Outcome Measure. This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3)). |
| Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | Baseline, after 1 and 4 years after vaccination | Seeding frequency S. pneumoniae from sputum in patients with COPD |
| CD45RO | Baseline, 1 and 4 years after vaccination | CD45RO expression on lymphocytes in serum at baseline, 1 and 4 years after vaccination. These patients were selected from patients of the main groups. |
| Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | Baseline, 1 and 12 months after vaccination | Mean specific IgG levels in vaccinated patients with COPD to S. pneumoniae serotypes at baseline, 6 and 12 months after vaccination |
| IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination in COPD | IgA, IgM, IgG, IgE, circulating immune complexes (CIC) in serum at baseline, 1, 2 and 6 weeks after vaccination. It was pre-specified to report data from only the COPD - Prevenar-13 and the COPD - Pneumo-23 Arms/Groups for this Outcome Measure. This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3)). |
| Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline, after 1 and 4 years after vaccination | CAT - COPD Assessment Test, min. = 0, max. = 40, higher scores mean a worse outcome. ACQ-5 - Asthma control questionnaire, min. = 0, max. = 6, higher scores mean a worse outcome. |
Countries
Russia
Participant flow
Recruitment details
IRB approval - 05 SEP 2012 (protocol #122, Samara State Medical University). Dates of recruitment period - 06 SEP 2012 - 07 JUL 2013. FPFV - 06 SEP 2012. LPLV - 07 JUL 2017. Types of location - Samara State Medical University, Institute of Sera and Vaccines RAS (Russian Federation).
Pre-assignment details
219 patients were examined and monitored for 4 years. Distributed in a row, first to the PCV13 group, then to the PPV23, PPV23/PCV13 and PCV13/PPV23 groups for COPD and asthma.
Participants by arm
| Arm | Count |
|---|---|
| COPD With Prevenar-13 (1) 33 patients with COPD. Standard therapy with Prevenar-13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine | 33 |
| Asthma With Prevenar 13 (2) 34 patients with asthma. Standard therapy with Prevenar 13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine | 34 |
| COPD With Pneumo-23 (3) 25 patients with COPD. Standard therapy with Pneumo-23.
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. | 25 |
| Asthma With Pneumo-23 (4) 25 patients with asthma. Standard therapy with Pneumo-23.
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. | 25 |
| COPD With Pneumo-23/Prevenar-13 (5) 32 patients with COPD. Standard therapy, vaccinated with PPV23/PCV13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. | 32 |
| Asthma With Pneumo-23/Prevenar-13 (6) 18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. | 18 |
| COPD With Prevenar-13/Pneumo-23 (7) 25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. | 25 |
| Asthma With Prevenar-13/Pneumo-23 (8) 27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. | 27 |
| Total | 219 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Asthma With Prevenar 13 (2) | COPD With Pneumo-23 (3) | Asthma With Pneumo-23 (4) | COPD With Pneumo-23/Prevenar-13 (5) | COPD With Prevenar-13 (1) | Asthma With Pneumo-23/Prevenar-13 (6) | COPD With Prevenar-13/Pneumo-23 (7) | Asthma With Prevenar-13/Pneumo-23 (8) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 11 Participants | 2 Participants | 14 Participants | 15 Participants | 2 Participants | 10 Participants | 5 Participants | 67 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 12 Participants | 23 Participants | 18 Participants | 17 Participants | 16 Participants | 15 Participants | 22 Participants | 148 Participants |
| Age, Continuous | 52.5 years STANDARD_DEVIATION 15.3 | 59 years STANDARD_DEVIATION 12.4 | 49.1 years STANDARD_DEVIATION 13.3 | 63.9 years STANDARD_DEVIATION 10.9 | 63.6 years STANDARD_DEVIATION 8.7 | 48.5 years STANDARD_DEVIATION 14.3 | 60.5 years STANDARD_DEVIATION 12.1 | 49.3 years STANDARD_DEVIATION 15.4 | 56.4 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment Russia | 33 participants | 23 participants | 25 participants | 32 participants | 32 participants | 18 participants | 25 participants | 27 participants | 215 participants |
| Sex: Female, Male Female | 22 Participants | 10 Participants | 19 Participants | 13 Participants | 11 Participants | 12 Participants | 7 Participants | 18 Participants | 112 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 6 Participants | 19 Participants | 21 Participants | 6 Participants | 18 Participants | 9 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 33 | 0 / 23 | 0 / 25 | 0 / 32 | 0 / 18 | 0 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 | 0 / 23 | 0 / 25 | 0 / 32 | 0 / 18 | 0 / 25 | 0 / 27 |
Outcome results
Primary
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Number of patients without exacerbations of the underlying disease, antibiotic use and hospitalisation.
Time frame: Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year after vaccination | 29 Participants |
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year prior to vaccination | 6 Participants |
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year prior to vaccination | 13 Participants |
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 4 years after vaccination | 12 Participants |
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 4 years after vaccination | 24 Participants |
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year after vaccination | 22 Participants |
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year after vaccination | 25 Participants |
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 4 years after vaccination | 10 Participants |
| COPD - Prevenar-13 (1) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year prior to vaccination | 3 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 4 years after vaccination | 11 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year prior to vaccination | 5 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year prior to vaccination | 12 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year after vaccination | 32 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year after vaccination | 29 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 4 years after vaccination | 27 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year after vaccination | 28 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 4 years after vaccination | 21 Participants |
| Asthma - Prevenar-13 (2) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year prior to vaccination | 18 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 4 years after vaccination | 4 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 4 years after vaccination | 5 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 4 years after vaccination | 13 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year after vaccination | 17 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year prior to vaccination | 1 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year after vaccination | 21 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year prior to vaccination | 2 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year prior to vaccination | 10 Participants |
| COPD - Pneumo-23 (3) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year after vaccination | 18 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year prior to vaccination | 6 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 4 years after vaccination | 4 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year after vaccination | 16 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year after vaccination | 24 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year after vaccination | 14 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 4 years after vaccination | 16 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year prior to vaccination | 15 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year prior to vaccination | 0 Participants |
| Asthma - Pneumo-23 (4) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 4 years after vaccination | 8 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year after vaccination | 14 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year prior to vaccination | 3 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year after vaccination | 11 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 4 years after vaccination | 2 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year prior to vaccination | 5 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 4 years after vaccination | 11 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year prior to vaccination | 15 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year after vaccination | 25 Participants |
| COPD - Pneumo-23/Prevenar-13 (5) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 4 years after vaccination | 21 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year after vaccination | 7 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year prior to vaccination | 1 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year prior to vaccination | 11 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 4 years after vaccination | 5 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year prior to vaccination | 4 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 4 years after vaccination | 14 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year after vaccination | 9 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year after vaccination | 17 Participants |
| Asthma - Pneumo-23/Prevenar-13 (6) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 4 years after vaccination | 7 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year after vaccination | 21 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year prior to vaccination | 1 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year after vaccination | 19 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year prior to vaccination | 9 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year prior to vaccination | 2 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 4 years after vaccination | 13 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year after vaccination | 18 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 4 years after vaccination | 23 Participants |
| COPD - Prevenar-13/Pneumo-23 (7) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 4 years after vaccination | 13 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 4 years after vaccination | 26 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 4 years after vaccination | 18 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year prior to vaccination | 7 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 4 years after vaccination | 13 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year prior to vaccination | 20 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year after vaccination | 20 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without hospitalisat, 1 year after vaccination | 21 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without exacerbations, 1 year prior to vaccination | 2 Participants |
| Asthma - Prevenar-13/Pneumo-23 (8) | Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation. | Without antibiotics, 1 year after vaccination | 16 Participants |
p-value: <0.05McNemar
Primary
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of exacerbations of the underlying disease, antibiotic use and hospitalisation. The average number of exacerbations per 1 patient = total exacerbations in the group / number of patients in the group. This is not a mean value.
Time frame: Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (1-st year) | 0.13 Events per 1 patient |
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (before vaccination) | 1.66 Events per 1 patient |
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (before vaccination) | 0.88 Events per 1 patient |
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (4-th year)) | 1.19 Events per 1 patient |
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (4-th year) | 0.63 Events per 1 patient |
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (1-st year) | 0.41 Events per 1 patient |
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (1-st year)) | 0.31 Events per 1 patient |
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (4-th year) | 1.16 Events per 1 patient |
| COPD - Prevenar-13 (1) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (before vaccination) | 1.97 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (4-th year) | 0.85 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (before vaccination) | 2.24 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (before vaccination) | 1.12 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (1-st year) | 0.03 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (1-st year)) | 0.12 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (4-th year) | 0.3 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (1-st year) | 0.24 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (4-th year)) | 0.69 Events per 1 patient |
| Asthma - Prevenar-13 (2) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (before vaccination) | 0.73 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (4-th year) | 1.52 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (4-th year)) | 1.69 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (4-th year) | 0.96 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (1-st year) | 0.35 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (before vaccination) | 2.13 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (1-st year) | 0.09 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (before vaccination) | 1.87 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (before vaccination) | 0.87 Events per 1 patient |
| COPD - Pneumo-23 (3) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (1-st year)) | 0.3 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (before vaccination) | 1.68 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (4-th year) | 1.2 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (1-st year)) | 0.56 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (1-st year) | 0.04 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (1-st year) | 0.64 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (4-th year) | 0.56 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (before vaccination) | 0.56 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (before vaccination) | 2.68 Events per 1 patient |
| Asthma - Pneumo-23 (4) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (4-th year)) | 1.44 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (1-st year)) | 1.59 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (before vaccination) | 2.22 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (1-st year) | 2.19 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (4-th year) | 1.72 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (before vaccination) | 1.91 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (4-th year)) | 1 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (before vaccination) | 0.94 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (1-st year) | 0.47 Events per 1 patient |
| COPD - Pneumo-23/Prevenar-13 (5) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (4-th year) | 0.47 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (1-st year) | 1.22 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (before vaccination) | 2.39 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (before vaccination) | 0.56 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (4-th year) | 1 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (before vaccination) | 1.72 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (4-th year) | 0.44 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (1-st year)) | 1.06 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (1-st year) | 0.06 Events per 1 patient |
| Asthma - Pneumo-23/Prevenar-13 (6) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (4-th year)) | 1.06 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (1-st year) | 0.16 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (before vaccination) | 2.52 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (1-st year)) | 0.24 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (before vaccination) | 0.84 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (before vaccination) | 2.12 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (4-th year) | 0.84 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (1-st year) | 0.32 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (4-th year) | 0.2 Events per 1 patient |
| COPD - Prevenar-13/Pneumo-23 (7) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (4-th year)) | 0.8 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (4-th year) | 0.04 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (4-th year)) | 0.56 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (before vaccination) | 1.44 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (4-th year) | 0.56 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (before vaccination) | 0.48 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (1-st year) | 0.44 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of hospitalisation (1-st year) | 0.26 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of exacerbations (before vaccination) | 1.89 Events per 1 patient |
| Asthma - Prevenar-13/Pneumo-23 (8) | The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation | The number of antibiotic use (1-st year)) | 0.48 Events per 1 patient |
p-value: <0.05McNemar
Secondary
Average CAT (COPD) and ACQ-5 (Asthma) Score
CAT - COPD Assessment Test, min. = 0, max. = 40, higher scores mean a worse outcome. ACQ-5 - Asthma control questionnaire, min. = 0, max. = 6, higher scores mean a worse outcome.
Time frame: Baseline, after 1 and 4 years after vaccination
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| COPD - Prevenar-13 (1) | Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline | 21.8 score on a scale |
| COPD - Prevenar-13 (1) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 4 years after vaccination | 18.2 score on a scale |
| COPD - Prevenar-13 (1) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 1 year after vaccination | 11.5 score on a scale |
| Asthma - Prevenar-13 (2) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 4 years after vaccination | 0.8 score on a scale |
| Asthma - Prevenar-13 (2) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 1 year after vaccination | 0.6 score on a scale |
| Asthma - Prevenar-13 (2) | Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline | 1.8 score on a scale |
| COPD - Pneumo-23 (3) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 4 years after vaccination | 20.5 score on a scale |
| COPD - Pneumo-23 (3) | Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline | 22.8 score on a scale |
| COPD - Pneumo-23 (3) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 1 year after vaccination | 14 score on a scale |
| Asthma - Pneumo-23 (4) | Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline | 2 score on a scale |
| Asthma - Pneumo-23 (4) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 1 year after vaccination | 0.8 score on a scale |
| Asthma - Pneumo-23 (4) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 4 years after vaccination | 1.4 score on a scale |
| COPD - Pneumo-23/Prevenar-13 (5) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 1 year after vaccination | 11.5 score on a scale |
| COPD - Pneumo-23/Prevenar-13 (5) | Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline | 16.8 score on a scale |
| COPD - Pneumo-23/Prevenar-13 (5) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 4 years after vaccination | 15.1 score on a scale |
| Asthma - Pneumo-23/Prevenar-13 (6) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 1 year after vaccination | 0.5 score on a scale |
| Asthma - Pneumo-23/Prevenar-13 (6) | Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline | 1.1 score on a scale |
| Asthma - Pneumo-23/Prevenar-13 (6) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 4 years after vaccination | 0.8 score on a scale |
| COPD - Prevenar-13/Pneumo-23 (7) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 1 year after vaccination | 11 score on a scale |
| COPD - Prevenar-13/Pneumo-23 (7) | Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline | 23.4 score on a scale |
| COPD - Prevenar-13/Pneumo-23 (7) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 4 years after vaccination | 19 score on a scale |
| Asthma - Prevenar-13/Pneumo-23 (8) | Average CAT (COPD) and ACQ-5 (Asthma) Score | Baseline | 1.6 score on a scale |
| Asthma - Prevenar-13/Pneumo-23 (8) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 1 year after vaccination | 0.4 score on a scale |
| Asthma - Prevenar-13/Pneumo-23 (8) | Average CAT (COPD) and ACQ-5 (Asthma) Score | 4 years after vaccination | 1 score on a scale |
Secondary
CD45RO
CD45RO expression on lymphocytes in serum at baseline, 1 and 4 years after vaccination. These patients were selected from patients of the main groups.
Time frame: Baseline, 1 and 4 years after vaccination
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD - Prevenar-13 (1) | CD45RO | CD45RO, baseline | 0.1 U | Standard Deviation 0.01 |
| COPD - Prevenar-13 (1) | CD45RO | CD45RO, 4 years after vaccination | 0.24 U | Standard Deviation 0.03 |
| COPD - Prevenar-13 (1) | CD45RO | CD45RO, 1 year after vaccination | 0.43 U | Standard Deviation 0.04 |
| Asthma - Prevenar-13 (2) | CD45RO | CD45RO, 4 years after vaccination | 0.2 U | Standard Deviation 0.015 |
| Asthma - Prevenar-13 (2) | CD45RO | CD45RO, 1 year after vaccination | 0.2 U | Standard Deviation 0.02 |
| Asthma - Prevenar-13 (2) | CD45RO | CD45RO, baseline | 0.1 U | Standard Deviation 0.01 |
| COPD - Pneumo-23 (3) | CD45RO | CD45RO, 4 years after vaccination | 0.05 U | Standard Deviation 0.01 |
| COPD - Pneumo-23 (3) | CD45RO | CD45RO, baseline | 0.1 U | Standard Deviation 0.01 |
| COPD - Pneumo-23 (3) | CD45RO | CD45RO, 1 year after vaccination | 0.1 U | Standard Deviation 0.01 |
| Asthma - Pneumo-23 (4) | CD45RO | CD45RO, baseline | 0.1 U | Standard Deviation 0.01 |
| Asthma - Pneumo-23 (4) | CD45RO | CD45RO, 1 year after vaccination | 0.15 U | Standard Deviation 0.01 |
| Asthma - Pneumo-23 (4) | CD45RO | CD45RO, 4 years after vaccination | 0.1 U | Standard Deviation 0.01 |
| COPD - Pneumo-23/Prevenar-13 (5) | CD45RO | CD45RO, 1 year after vaccination | 0.47 U | Standard Deviation 0.06 |
| COPD - Pneumo-23/Prevenar-13 (5) | CD45RO | CD45RO, baseline | 0.1 U | Standard Deviation 0.01 |
| COPD - Pneumo-23/Prevenar-13 (5) | CD45RO | CD45RO, 4 years after vaccination | 0.31 U | Standard Deviation 0.02 |
| Asthma - Pneumo-23/Prevenar-13 (6) | CD45RO | CD45RO, 1 year after vaccination | 0.67 U | Standard Deviation 0.13 |
| Asthma - Pneumo-23/Prevenar-13 (6) | CD45RO | CD45RO, baseline | 0.1 U | Standard Deviation 0.01 |
| Asthma - Pneumo-23/Prevenar-13 (6) | CD45RO | CD45RO, 4 years after vaccination | 0.32 U | Standard Deviation 0.08 |
| COPD - Prevenar-13/Pneumo-23 (7) | CD45RO | CD45RO, 1 year after vaccination | 0.71 U | Standard Deviation 0.12 |
| COPD - Prevenar-13/Pneumo-23 (7) | CD45RO | CD45RO, baseline | 0.1 U | Standard Deviation 0.01 |
| COPD - Prevenar-13/Pneumo-23 (7) | CD45RO | CD45RO, 4 years after vaccination | 0.59 U | Standard Deviation 0.1 |
| Asthma - Prevenar-13/Pneumo-23 (8) | CD45RO | CD45RO, baseline | 0.1 U | Standard Deviation 0.01 |
| Asthma - Prevenar-13/Pneumo-23 (8) | CD45RO | CD45RO, 1 year after vaccination | 0.73 U | Standard Deviation 0.15 |
| Asthma - Prevenar-13/Pneumo-23 (8) | CD45RO | CD45RO, 4 years after vaccination | 0.59 U | Standard Deviation 0.12 |
Secondary
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgA, IgM, IgG, IgE, circulating immune complexes (CIC) in serum at baseline, 1, 2 and 6 weeks after vaccination. It was pre-specified to report data from only the COPD - Prevenar-13 and the COPD - Pneumo-23 Arms/Groups for this Outcome Measure. This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3)).
Time frame: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination in COPD
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgA, baseline | 3.57 g/l | Standard Deviation 1.18 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgA, 1 week after vaccination | 3.74 g/l | Standard Deviation 1.25 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgA, 2 weeks after vaccination | 3.79 g/l | Standard Deviation 1.26 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgA, 6 weeks after vaccination | 3.63 g/l | Standard Deviation 1.13 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgM, baseline | 1 g/l | Standard Deviation 0.21 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgM, 1 week after vaccination | 1.25 g/l | Standard Deviation 0.62 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgM, 2 weeks after vaccination | 1 g/l | Standard Deviation 0.17 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgM, 6 weeks after vaccination | 1 g/l | Standard Deviation 0.23 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgG, baseline | 12.8 g/l | Standard Deviation 1.13 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgG, 1 week after vaccination | 12.9 g/l | Standard Deviation 0.8 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgG, 2 weeks after vaccination | 13.4 g/l | Standard Deviation 1.04 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgG, 6 weeks after vaccination | 13.1 g/l | Standard Deviation 0.57 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgE, baseline | 120 g/l | Standard Deviation 42 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgE, 1 week after vaccination | 126 g/l | Standard Deviation 87 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgE, 2 weeks after vaccination | 118 g/l | Standard Deviation 74 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgE, 6 weeks after vaccination | 119 g/l | Standard Deviation 51 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | CIC, baseline | 0.067 g/l | Standard Deviation 0.02 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | CIC, 1 week after vaccination | 0.086 g/l | Standard Deviation 0.01 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | CIC, 2 weeks after vaccination | 0.079 g/l | Standard Deviation 0.015 |
| COPD - Prevenar-13 (1) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | CIC, 6 weeks after vaccination | 0.073 g/l | Standard Deviation 0.016 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | CIC, 1 week after vaccination | 0.077 g/l | Standard Deviation 0.01 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgA, baseline | 3.33 g/l | Standard Deviation 0.55 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgG, 2 weeks after vaccination | 11.9 g/l | Standard Deviation 2.5 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgA, 1 week after vaccination | 3.39 g/l | Standard Deviation 0.58 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgE, 6 weeks after vaccination | 120 g/l | Standard Deviation 35 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgA, 2 weeks after vaccination | 3.52 g/l | Standard Deviation 0.58 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgG, 6 weeks after vaccination | 11.8 g/l | Standard Deviation 2.5 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgA, 6 weeks after vaccination | 3.56 g/l | Standard Deviation 0.61 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | CIC, 6 weeks after vaccination | 0.079 g/l | Standard Deviation 0.01 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgM, baseline | 1.26 g/l | Standard Deviation 0.47 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgE, baseline | 120 g/l | Standard Deviation 39 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgM, 1 week after vaccination | 1.3 g/l | Standard Deviation 0.47 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | CIC, baseline | 0.073 g/l | Standard Deviation 0.01 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgM, 2 weeks after vaccination | 1.3 g/l | Standard Deviation 0.51 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgE, 1 week after vaccination | 118 g/l | Standard Deviation 42 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgM, 6 weeks after vaccination | 1.34 g/l | Standard Deviation 0.49 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | CIC, 2 weeks after vaccination | 0.08 g/l | Standard Deviation 0.01 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgG, baseline | 11.6 g/l | Standard Deviation 2.5 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgE, 2 weeks after vaccination | 120 g/l | Standard Deviation 34 |
| Asthma - Prevenar-13 (2) | IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC) | IgG, 1 week after vaccination | 11.7 g/l | Standard Deviation 2.5 |
Secondary
Immunophenotype of Blood Lymphocytes in Patients With COPD
Immunophenotype of blood lymphocytes in patients with COPD at baseline, 1, 2 and 6 weeks after PCV13 and PPV23 vaccination. It was pre-specified to report data from only the COPD - Prevenar-13 and the COPD - Pneumo-23 Arms/Groups for this Outcome Measure. This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3)).
Time frame: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination
Population: CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+CD56+, CD3+CD16+CD56+, CD3-HLA DR+, CD3+HLA DR+
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD8+, baseline | 26.2 % of cells | Standard Deviation 6.9 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+, 1 week after vaccination | 69.7 % of cells | Standard Deviation 3.8 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+, 2 weeks after vaccination | 69 % of cells | Standard Deviation 2.8 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+, 6 weeks after vaccination | 66.9 % of cells | Standard Deviation 3.7 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD4+, baseline | 35.9 % of cells | Standard Deviation 7.6 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD4+, 1 week after vaccination | 40.7 % of cells | Standard Deviation 4.5 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD4+, 2 weeks after vaccination | 39.4 % of cells | Standard Deviation 5.8 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD4+, 6 weeks after vaccination | 38.9 % of cells | Standard Deviation 5.4 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+, baseline | 67.3 % of cells | Standard Deviation 4.8 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD8+, 1 week after vaccination | 23.5 % of cells | Standard Deviation 3.5 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD8+, 2 weeks after vaccination | 32.4 % of cells | Standard Deviation 5.1 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD8+, 6 weeks after vaccination | 33.3 % of cells | Standard Deviation 5.2 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD19+, baseline | 12.5 % of cells | Standard Deviation 3.9 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD19+, 1 week after vaccination | 13.3 % of cells | Standard Deviation 3 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD19+, 2 weeks after vaccination | 11 % of cells | Standard Deviation 2.5 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD19+, 6 weeks after vaccination | 15.1 % of cells | Standard Deviation 3.8 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-CD16+CD56+, baseline | 18.3 % of cells | Standard Deviation 3.9 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-CD16+CD56+, 1 week after vaccination | 14 % of cells | Standard Deviation 3 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-CD16+CD56+, 2 weeks after vaccination | 13 % of cells | Standard Deviation 3.9 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-CD16+CD56+, 6 weeks after vaccination | 16.8 % of cells | Standard Deviation 3.7 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD16+CD56+, baseline | 11 % of cells | Standard Deviation 3.8 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD16+CD56+, 1 week after vaccination | 11 % of cells | Standard Deviation 4.2 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD16+CD56+, 2 weeks after vaccination | 22.5 % of cells | Standard Deviation 7.3 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD16+CD56+, 6 weeks after vaccination | 17 % of cells | Standard Deviation 5.3 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-HLA DR+, baseline | 8.6 % of cells | Standard Deviation 4.2 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-HLA DR+, 1 week after vaccination | 13 % of cells | Standard Deviation 3.8 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-HLA DR+, 2 weeks after vaccination | 7 % of cells | Standard Deviation 4.9 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-HLA DR+, 6 weeks after vaccination | 9.5 % of cells | Standard Deviation 5.1 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+HLA DR+, baseline | 12.1 % of cells | Standard Deviation 3.5 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+HLA DR+, 1 week after vaccination | 11.8 % of cells | Standard Deviation 4.2 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+HLA DR+, 2 weeks after vaccination | 10.1 % of cells | Standard Deviation 3.2 |
| COPD - Prevenar-13 (1) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+HLA DR+, 6 weeks after vaccination | 16.2 % of cells | Standard Deviation 4.5 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+HLA DR+, 6 weeks after vaccination | 11.6 % of cells | Standard Deviation 1.5 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+, baseline | 69.6 % of cells | Standard Deviation 5.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-CD16+CD56+, baseline | 17.3 % of cells | Standard Deviation 2.3 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+, 1 week after vaccination | 69.9 % of cells | Standard Deviation 6.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-HLA DR+, baseline | 10.7 % of cells | Standard Deviation 2.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+, 2 weeks after vaccination | 71.3 % of cells | Standard Deviation 5.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-CD16+CD56+, 1 week after vaccination | 16.6 % of cells | Standard Deviation 2.2 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+, 6 weeks after vaccination | 69.9 % of cells | Standard Deviation 6.1 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+HLA DR+, baseline | 11.5 % of cells | Standard Deviation 1.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD4+, baseline | 35.9 % of cells | Standard Deviation 2.2 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-CD16+CD56+, 2 weeks after vaccination | 16.2 % of cells | Standard Deviation 2.2 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD4+, 1 week after vaccination | 37.3 % of cells | Standard Deviation 2.7 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-HLA DR+, 1 week after vaccination | 11.9 % of cells | Standard Deviation 2.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD4+, 2 weeks after vaccination | 36.9 % of cells | Standard Deviation 2.8 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-CD16+CD56+, 6 weeks after vaccination | 16.7 % of cells | Standard Deviation 2.2 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD4+, 6 weeks after vaccination | 37.8 % of cells | Standard Deviation 2.5 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+HLA DR+, 2 weeks after vaccination | 12.3 % of cells | Standard Deviation 1.5 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD8+, baseline | 26.7 % of cells | Standard Deviation 2.5 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD16+CD56+, baseline | 10.6 % of cells | Standard Deviation 2.6 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD8+, 1 week after vaccination | 26.9 % of cells | Standard Deviation 2.3 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-HLA DR+, 2 weeks after vaccination | 12.3 % of cells | Standard Deviation 2.4 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD8+, 2 weeks after vaccination | 27.6 % of cells | Standard Deviation 1.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD16+CD56+, 1 week after vaccination | 11.9 % of cells | Standard Deviation 2.3 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD8+, 6 weeks after vaccination | 27.9 % of cells | Standard Deviation 1.2 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+HLA DR+, 1 week after vaccination | 12.5 % of cells | Standard Deviation 1.3 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD19+, baseline | 13.7 % of cells | Standard Deviation 3.3 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD16+CD56+, 2 weeks after vaccination | 11.8 % of cells | Standard Deviation 2.6 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD19+, 1 week after vaccination | 15.6 % of cells | Standard Deviation 2.7 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3-HLA DR+, 6 weeks after vaccination | 11.3 % of cells | Standard Deviation 2.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD19+, 2 weeks after vaccination | 14.9 % of cells | Standard Deviation 2.9 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD3+CD16+CD56+, 6 weeks after vaccination | 10.8 % of cells | Standard Deviation 2.2 |
| Asthma - Prevenar-13 (2) | Immunophenotype of Blood Lymphocytes in Patients With COPD | CD19+, 6 weeks after vaccination | 14.5 % of cells | Standard Deviation 3.1 |
Secondary
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (granulocytes), phagocytic index (monocytes), activity of a spontaneous HCT test (neutrophils), activity of an induced HCT test (neutrophils), percentage of HCT-positive white blood cells in a spontaneous test. The phagocytic index was calculated according to the following formula: phagocytic index = (total number of engulfed cells/total number of counted macrophages) × (number of macrophages containing engulfed cells/total number of counted macrophages) × 100 (phagocytic index) The phagocytic index was calculated by counting at least 100 bacteria phagocytized by certain number of phagocytic cells/macrophages and expressed following formula (Mamnur Rashid 1997): Phagocytic index = Total no. of phagocytized bacteria /No of phagocytic cells phagocytizing bacteria. Activation index = % formazan positive cells (FPC) in NBT stimulated / % formazan positive cells (FPC) in NBT Spontaneous.
Time frame: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination
Population: Phagocytic index (granulocytes) - %, phagocytic index (monocytes) - %, activity of a spontaneous HCT test (neutrophils) - %, activity of an induced HCT test (neutrophils) - %, percentage of HCT-positive white blood cells in a spontaneous test - %.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (granulocytes) - baseline | 65 score on a scale | Standard Deviation 7.6 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (granulocytes) - 1 week | 71 score on a scale | Standard Deviation 8.2 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (granulocytes) - 2 weeks | 84 score on a scale | Standard Deviation 3.6 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (granulocytes) - 6 weeks | 85 score on a scale | Standard Deviation 3.2 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (monocytes) - baseline | 72.1 score on a scale | Standard Deviation 5.4 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (monocytes) - 1 week | 74.1 score on a scale | Standard Deviation 4.6 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (monocytes) - 2 weeks | 74.4 score on a scale | Standard Deviation 4.5 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (monocytes) - 6 weeks | 77.3 score on a scale | Standard Deviation 3.7 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of a spontaneous HCT test - baseline | 4 score on a scale | Standard Deviation 1.3 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of a spontaneous HCT test - 1 week | 7.5 score on a scale | Standard Deviation 3.1 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of a spontaneous HCT test - 2 weeks | 12.5 score on a scale | Standard Deviation 4.7 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of a spontaneous HCT test - 6 weeks | 14.1 score on a scale | Standard Deviation 4.4 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of an induced HCT test - baseline | 11 score on a scale | Standard Deviation 3.4 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of an induced HCT test - 1 week | 15 score on a scale | Standard Deviation 2.9 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of an induced HCT test - 2 weeks | 22 score on a scale | Standard Deviation 3.1 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of an induced HCT test - 6 weeks | 26 score on a scale | Standard Deviation 3.4 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | percentage of HCT-positive cells - baseline | 7 score on a scale | Standard Deviation 3.2 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | percentage of HCT-positive cells - 1 week | 11 score on a scale | Standard Deviation 2.6 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | percentage of HCT-positive cells - 2 weeks | 15 score on a scale | Standard Deviation 2.9 |
| COPD - Prevenar-13 (1) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | percentage of HCT-positive cells - 6 weeks | 17 score on a scale | Standard Deviation 3.6 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | percentage of HCT-positive cells - 1 week | 7.4 score on a scale | Standard Deviation 2.3 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (granulocytes) - baseline | 63 score on a scale | Standard Deviation 5.5 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of a spontaneous HCT test - 2 weeks | 7.2 score on a scale | Standard Deviation 1.9 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (granulocytes) - 1 week | 65 score on a scale | Standard Deviation 5.4 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of an induced HCT test - 6 weeks | 10.9 score on a scale | Standard Deviation 3.8 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (granulocytes) - 2 weeks | 64.3 score on a scale | Standard Deviation 4.8 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of a spontaneous HCT test - 6 weeks | 6.9 score on a scale | Standard Deviation 1.8 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (granulocytes) - 6 weeks | 66.5 score on a scale | Standard Deviation 5.8 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | percentage of HCT-positive cells - 6 weeks | 6.7 score on a scale | Standard Deviation 1.8 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (monocytes) - baseline | 74.6 score on a scale | Standard Deviation 5.2 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of an induced HCT test - baseline | 9.3 score on a scale | Standard Deviation 2.6 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (monocytes) - 1 week | 75.3 score on a scale | Standard Deviation 5.7 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | percentage of HCT-positive cells - baseline | 6 score on a scale | Standard Deviation 2 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (monocytes) - 2 weeks | 76.3 score on a scale | Standard Deviation 4.1 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of an induced HCT test - 1 week | 10.8 score on a scale | Standard Deviation 2.2 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | Phagocytic index (monocytes) - 6 weeks | 78.1 score on a scale | Standard Deviation 6.6 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | percentage of HCT-positive cells - 2 weeks | 7.2 score on a scale | Standard Deviation 1.9 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of a spontaneous HCT test - baseline | 5 score on a scale | Standard Deviation 2.2 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of an induced HCT test - 2 weeks | 10.4 score on a scale | Standard Deviation 3.3 |
| Asthma - Prevenar-13 (2) | Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination | activity of a spontaneous HCT test - 1 week | 5 score on a scale | Standard Deviation 2.3 |
Secondary
Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD
Seeding frequency S. pneumoniae from sputum in patients with COPD
Time frame: Baseline, after 1 and 4 years after vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD - Prevenar-13 (1) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum at baseline | 21 Number of Participants with S. Pneumonia |
| COPD - Prevenar-13 (1) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 4 years | 14 Number of Participants with S. Pneumonia |
| COPD - Prevenar-13 (1) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 1 year | 2 Number of Participants with S. Pneumonia |
| Asthma - Prevenar-13 (2) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 4 years | 5 Number of Participants with S. Pneumonia |
| Asthma - Prevenar-13 (2) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 1 year | 0 Number of Participants with S. Pneumonia |
| Asthma - Prevenar-13 (2) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum at baseline | 12 Number of Participants with S. Pneumonia |
| COPD - Pneumo-23 (3) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 4 years | 12 Number of Participants with S. Pneumonia |
| COPD - Pneumo-23 (3) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum at baseline | 18 Number of Participants with S. Pneumonia |
| COPD - Pneumo-23 (3) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 1 year | 5 Number of Participants with S. Pneumonia |
| Asthma - Pneumo-23 (4) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum at baseline | 10 Number of Participants with S. Pneumonia |
| Asthma - Pneumo-23 (4) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 1 year | 4 Number of Participants with S. Pneumonia |
| Asthma - Pneumo-23 (4) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 4 years | 6 Number of Participants with S. Pneumonia |
| COPD - Pneumo-23/Prevenar-13 (5) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 1 year | 1 Number of Participants with S. Pneumonia |
| COPD - Pneumo-23/Prevenar-13 (5) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum at baseline | 18 Number of Participants with S. Pneumonia |
| COPD - Pneumo-23/Prevenar-13 (5) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 4 years | 10 Number of Participants with S. Pneumonia |
| Asthma - Pneumo-23/Prevenar-13 (6) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 1 year | 0 Number of Participants with S. Pneumonia |
| Asthma - Pneumo-23/Prevenar-13 (6) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum at baseline | 5 Number of Participants with S. Pneumonia |
| Asthma - Pneumo-23/Prevenar-13 (6) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 4 years | 3 Number of Participants with S. Pneumonia |
| COPD - Prevenar-13/Pneumo-23 (7) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 1 year | 0 Number of Participants with S. Pneumonia |
| COPD - Prevenar-13/Pneumo-23 (7) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum at baseline | 14 Number of Participants with S. Pneumonia |
| COPD - Prevenar-13/Pneumo-23 (7) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 4 years | 6 Number of Participants with S. Pneumonia |
| Asthma - Prevenar-13/Pneumo-23 (8) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum at baseline | 12 Number of Participants with S. Pneumonia |
| Asthma - Prevenar-13/Pneumo-23 (8) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 1 year | 0 Number of Participants with S. Pneumonia |
| Asthma - Prevenar-13/Pneumo-23 (8) | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | S. pneumoniae in sputum after 4 years | 2 Number of Participants with S. Pneumonia |
Secondary
Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes
Mean specific IgG levels in vaccinated patients with COPD to S. pneumoniae serotypes at baseline, 6 and 12 months after vaccination
Time frame: Baseline, 1 and 12 months after vaccination
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| COPD - Prevenar-13 (1) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | 6 months after vaccination | 132.7 U/ml |
| COPD - Prevenar-13 (1) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | 12 months after vaccination | 112.9 U/ml |
| COPD - Prevenar-13 (1) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | Baseline | 69.7 U/ml |
| Asthma - Prevenar-13 (2) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | Baseline | 66.9 U/ml |
| Asthma - Prevenar-13 (2) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | 12 months after vaccination | 94.9 U/ml |
| Asthma - Prevenar-13 (2) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | 6 months after vaccination | 106.9 U/ml |
| COPD - Pneumo-23 (3) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | 6 months after vaccination | 119.4 U/ml |
| COPD - Pneumo-23 (3) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | Baseline | 87.5 U/ml |
| COPD - Pneumo-23 (3) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | 12 months after vaccination | 0 U/ml |
| Asthma - Pneumo-23 (4) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | Baseline | 88 U/ml |
| Asthma - Pneumo-23 (4) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | 12 months after vaccination | 136 U/ml |
| Asthma - Pneumo-23 (4) | Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes | 6 months after vaccination | 142.2 U/ml |