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StaphVAX Immunogenicity in Orthopedic Implant Patients

NCT00211926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-01-04

No results posted yet for this study

Summary

S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.

Conditions

  • Staphylococcal Infections
  • Joint Prosthesis

Interventions

BIOLOGICAL

S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

single dose of vaccine containing 100 mcg of each serotype conjugate

BIOLOGICAL

placebo

single dose of placebo

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Preston Holley, MD · Nabi Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-06-30
Completion
2006-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00211926 on ClinicalTrials.gov