CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 219 enrolled
Drug / intervention
Prevenar-13 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02787863
NCT02787863Phase 4Completed
CompareCT.gov

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

Mikhael Petrovich Kostinov·interventional·Posted Jun 1, 2016·Updated Feb 25, 2020

In Brief

A Phase 4 clinical trial evaluating Prevenar-13 and Pneumo-23 for Chronic Obstructive Pulmonary Disease and 2 related conditions. Completed, enrolled 219 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease, Asthma, Pneumococcal Infections
CountriesRussia
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2016
Enrollment StartSep 6, 2012
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.1 years ago

Interventions

Prevenar-13biological

Conjugate 13 serotype pneumococcal vaccine

Pneumo-23biological

Polysaccharide 23-valent pneumococcal vaccine.