Status:
UNKNOWN
Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)
Lead Sponsor:
JHP Pharmaceuticals LLC
Collaborating Sponsors:
Syneos Health
Conditions:
Tuberculosis Identification.
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 subje...
Eligibility Criteria
Inclusion
- Males or nonpregnant females age 18 to 60 years
- Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be acc
- Give written informed consent to participate
- Generally healthy, as determined by medical history and targeted physical examination, if indicated
- Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar
- Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina
Exclusion
- Prior PPD test within the past 30 days
- Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in
- Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is
- Presence of conditions that may suppress TST reactivity -
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01798121
Start Date
February 1 2013
End Date
July 1 2013
Last Update
February 25 2013
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