Equivalence Study of Specificity of PPD — 03  

Tuberculosis Infection Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

Determine if investigational products and reference standard produce similar responses.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis Infection

• NCT number: NCT01798095
• Study type: Interventional
• Source: JHP Pharmaceuticals LLC
• Contact: Arlene Lund, B.Sc.
• Phone: 919-985-3220
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2013
• Completion date: July 2013