NCT01798095

Equivalence Study of Specificity of PPD

A Randomized, Double-blind, Equivalence Study of the Specificity of Tuberculin Purified Protein Derivative (PPD) (Aplisol®) in Comparison With a Reference Standard

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: JHP Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Determine if investigational products and reference standard produce similar responses.

Detailed description

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.

Conditions

• Tuberculosis Infection

Interventions

Type	Name	Description
BIOLOGICAL	Aplisol@ PPD material	Determine equivalency of materials
BIOLOGICAL	Reference Standard	Reference standard material for comparison to newly produced materials.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2013-02-25
• Last updated: 2013-02-25

Locations

1 site across 1 country: United States