Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)
Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)
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.
Additional information in the protocol
Inclusion Criteria:

 To be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate
 written informed consent for C-041-972. See NCT 01755598 for inclusion criteria into
 TB-018.

 Exclusion criteria:

 To be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate
 written informed consent for C-041-972. See NCT 01755598 for exclusion criteria into
 TB-018.