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Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine

NCT03017378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-01-11

No results posted yet for this study

Summary

The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.

Conditions

Interventions

BIOLOGICAL

TB/FLU-01L

TB / FLU-01L (intranasal application)

BIOLOGICAL

TB/FLU-01L

TB/FLU-01L (sublingual application)

Sponsors & Collaborators

  • Ministry of Health, Kazakhstan

    collaborator OTHER_GOV

  • Research Institute of Influenza, Russia

    collaborator OTHER

  • Research Institute for Biological Safety Problems

    lead OTHER_GOV

Principal Investigators

  • Berik M Khairullin, PhD · Research Institute for Biological Safety Problems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2015-02-28

Countries

  • Kazakhstan

More Related Trials

Entities

Diseases

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 NCT03017378 on ClinicalTrials.gov