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Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology

NCT02787863 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2020-02-25

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Prevenar-13

Conjugate 13 serotype pneumococcal vaccine

BIOLOGICAL

Pneumo-23

Polysaccharide 23-valent pneumococcal vaccine.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Mikhael Petrovich Kostinov

    lead OTHER

Principal Investigators

  • Andrei D Protasov, Professor · Samara State Medical University

  • Mikhael P Kostinov, Professor · Institute of Sera and Vaccines RAS, Moscow

  • Mikhael P Kostinov, Professor · Institute of Sera and Vaccines RAS, Moscow

  • Aleksander V Zhestkov, Professor · Samara State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-06
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Russia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787863 on ClinicalTrials.gov