NCT01798121

Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)

A Randomized, Double-blind, Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard Tuberculin Purified Protein Derivative (PPD-S2) for Detection of Tuberculosis in Subjects With a Confirmed Diagnosis of Tuberculosis.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: JHP Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A study to determine bioequivalence of PPD material versus Reference Standard.

Detailed description

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).

Conditions

• Tuberculosis Identification.

Interventions

Type	Name	Description
BIOLOGICAL	To compare new PPD to reference standard material	Aplisol@ will be compared to reference standard material
BIOLOGICAL	Reference standard	Response of reference standard material compared to Aplisol@.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2013-02-25
• Last updated: 2013-02-25