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Evaluation of Consistency of StaphVAX Manufacturing Lots

NCT00211991 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2012-05-14

No results posted yet for this study

Summary

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.

Conditions

  • Staphylococcal Infections

Interventions

BIOLOGICAL

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Sponsors & Collaborators

  • Vanderbilt University

    collaborator OTHER

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Matt Hohenboken, MD, PhD · Nabi Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2005-07-31
Completion
2005-07-31

Countries

  • United States

Study Locations

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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 NCT00211991 on ClinicalTrials.gov