Equivalence Study of Specificity of PPD

Determine if investigational products and reference standard produce similar responses.

Primary:

To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.

Secondary:

1. To determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with Mtb; 2. To assess the tolerability of the investigational products in terms of the local and systemic reactogenicity events.