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

NCT01798121 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-02-25

No results posted yet for this study

Summary

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

Conditions

  • Tuberculosis Identification.

Interventions

BIOLOGICAL

To compare new PPD to reference standard material

Aplisol@ will be compared to reference standard material

BIOLOGICAL

Reference standard

Response of reference standard material compared to Aplisol@.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • JHP Pharmaceuticals LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-03-31
Completion
2013-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01798121 on ClinicalTrials.gov