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Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults

NCT00730795 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2008-08-08

No results posted yet for this study

Summary

This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.

Conditions

  • Tuberculosis (TB)

Interventions

BIOLOGICAL

GSK's candidate Mycobacterium tuberculosis vaccine 692342

Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2004-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT00730795 on ClinicalTrials.gov