Trial | NCT01689831  Report issue

Title

Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)
Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Tuberculin, Purified Protein Derivative ...

  • Study Participants

    168
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.
Study Started
May 31
2012
Primary Completion
Oct 31
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Sep 21
2012
Estimate

Biological To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.

Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.

Biological Reactivity of Aplisol compared to reference standard PPD-S2.

Reference standard PPD-S2 formulated to contain different dose concentrations.

  • Other names: Reference standard PPD-S2.

Aplisol, potency determination Experimental

To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.

Reference standard PPD-S2, reference Active Comparator

Reactivity of Aplisol compared to reference standard PPD-S2.

Criteria 

Inclusion Criteria:

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 accepted if medical records cannot be obtained.
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 preparation or the readings of the injections
Comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours

Exclusion Criteria:

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 the past
Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is uncertain of his/her BCG vaccination status
Presence of conditions that may suppress TST reactivity
No Results Posted