Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)
02
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.
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
A study to determine bioequivalence of PPD material versus Reference Standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2013
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFebruary 25, 2013
February 1, 2013
28 days
January 31, 2013
February 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Aplisol
EXPERIMENTALTo compare new PPD to reference standard material
Reference standard
PLACEBO COMPARATORResponse of standard material
Interventions
Aplisol@ will be compared to reference standard material
Response of reference standard material compared to Aplisol@.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JHP Pharmaceuticals LLClead
- Syneos Healthcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 25, 2013
Study Start
February 1, 2013
Primary Completion
March 1, 2013
Study Completion
July 1, 2013
Last Updated
February 25, 2013
Record last verified: 2013-02