Tuberculosis Identification. Clinical Trial
— 02Official title:
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.
A study to determine bioequivalence of PPD material versus Reference Standard.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | July 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Males or nonpregnant females age 18 to 60 years 2. Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be acc 3. Give written informed consent to participate 4. Generally healthy, as determined by medical history and targeted physical examination, if indicated 5. Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar 6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina Exclusion Criteria: 1. Prior PPD test within the past 30 days 2. Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating 3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in 4. Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is 5. Presence of conditions that may suppress TST reactivity - |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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JHP Pharmaceuticals LLC | INC Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare new PPD to Reference Standard | Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients. | 72 hours | No |