Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 8:57 AM
Study NCT ID:
NCT01798095
Status:
UNKNOWN
Last Update Posted:
2013-02-25
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Equivalence Study of Specificity of PPD
Sponsor:
JHP Pharmaceuticals LLC
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
03
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: