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

February 21, 2013 updated by: JHP Pharmaceuticals LLC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Aplisol@
Biological: Reference standard
Response of reference standard material compared to Aplisol@.
Other Names:
  • 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 Names:
  • Aplisol@

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JHP Pharmaceuticals LLC

Collaborators

Syneos Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHP-Aplisol-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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