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Evaluation of Manufacturing Lot of StaphVAX

NCT00211900 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2008-01-04

No results posted yet for this study

Summary

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.

Conditions

  • Staphylococcal Infections
  • Chronic Kidney Failure

Interventions

BIOLOGICAL

S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine

single IM dose totalling 200 mcg of conjugate

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Matt Hohenboken, MD, PhD · Nabi Biopharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-08-31
Completion
2005-11-30

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 NCT00211900 on ClinicalTrials.gov