Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
NCT02787863
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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
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.
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Descriptive Information | |||||||||||||
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Brief Title ICMJE | Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology | ||||||||||||
Official Title ICMJE | Pathogenetic Justification and Clinical and Immunological Efficiency of Application Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology | ||||||||||||
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:
Characteristics of variables (arms 1-8).
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 4 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE | 219 | ||||||||||||
Original Estimated Enrollment ICMJE | 520 | ||||||||||||
Actual Study Completion Date ICMJE | December 31, 2016 | ||||||||||||
Actual Primary Completion Date | December 31, 2016 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Russian Federation | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT02787863 | ||||||||||||
Other Study ID Numbers ICMJE | 115030370013 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Mikhael Petrovich Kostinov, Russian Academy of Medical Sciences | ||||||||||||
Study Sponsor ICMJE | Mikhael Petrovich Kostinov | ||||||||||||
Collaborators ICMJE | Pfizer | ||||||||||||
Investigators ICMJE |
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PRS Account | Russian Academy of Medical Sciences | ||||||||||||
Verification Date | February 2020 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |