ABOUT THIS STUDY
- 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.
- 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
- History of chronic alcohol abuse and/or drug use;
- Exacerbation of chronic diseases;
- Participation in any other clinical study within the last 3 months.
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