A study to determine bioequivalence of PPD material versus Reference Standard.
This study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced PPD material versus PPD-S2 in the detection of male and female subjects with current or previously diagnosed intrathoracic Mtb infection, as documented by a positive culture for Mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
90
Aplisol@ will be compared to reference standard material
Response of reference standard material compared to Aplisol@.
Compare new PPD to Reference Standard
Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients.
Time frame: 72 hours
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