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Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2) (02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798121
Recruitment Status : Unknown
Verified February 2013 by JHP Pharmaceuticals LLC.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2013
Last Update Posted : February 25, 2013
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
JHP Pharmaceuticals LLC

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

Condition or disease Intervention/treatment Phase
Tuberculosis Identification. Biological: To compare new PPD to reference standard material Biological: Reference standard Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official 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.
Study Start Date : February 2013
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Aplisol
To compare new PPD to reference standard material
Biological: To compare new PPD to reference standard material
Aplisol@ will be compared to reference standard material
Other Name: Aplisol@

Biological: Reference standard
Response of reference standard material compared to Aplisol@.
Other Name: Tuberculin PPD Standard.

Placebo Comparator: Reference standard
Response of standard material
Biological: To compare new PPD to reference standard material
Aplisol@ will be compared to reference standard material
Other Name: Aplisol@




Primary Outcome Measures :
  1. Compare new PPD to Reference Standard [ Time Frame: 72 hours ]
    Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798121


Contacts
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Contact: Arlene Lund, B.Sc. 919-985-3220 arlene.lund@incresearch.com

Sponsors and Collaborators
JHP Pharmaceuticals LLC
Syneos Health
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Responsible Party: JHP Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01798121    
Other Study ID Numbers: JHP-Aplisol-02
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Keywords provided by JHP Pharmaceuticals LLC:
PPD
Tuberculosis
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections