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Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)

NCT02097095 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3253

Last updated 2017-02-01

No results posted yet for this study

Summary

This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which biological samples will be collected for future investigations on biological correlates, markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, "A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342 (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic region", (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but will have additional blood samples collected for the sub-study.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Bernard Landry, MS · Aeras

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-11-30
Completion
2016-11-30

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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 NCT02097095 on ClinicalTrials.gov