Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
168
Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
Reference standard PPD-S2 formulated to contain different dose concentrations.
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
RECRUITINGConfirm the potency of Aplisol equipotent to PPD-S2.
Time frame: 72 hours
Assess tolerability of Aplisol with new tuberculin PPD
Time frame: 72 hours
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