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Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine

NCT02501421 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-08-28

No results posted yet for this study

Summary

The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged 18-50 years.

Conditions

Interventions

BIOLOGICAL

tuberculosis vaccine

Live recombinant influenza vectored tuberculosis vaccine

BIOLOGICAL

Placebo

Buffer

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
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

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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 NCT02501421 on ClinicalTrials.gov