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Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)

NCT01689831 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2012-09-21

No results posted yet for this study

Summary

Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).

Conditions

  • Tuberculosis Infection

Interventions

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.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • JHP Pharmaceuticals LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01689831 on ClinicalTrials.gov