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StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

NCT00211965 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2008-01-04

No results posted yet for this study

Summary

Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for orthopedic surgery.

Conditions

  • Staphylococcal Infections

Interventions

BIOLOGICAL

S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate

single IM dose of 200 mcg total conjugate

BIOLOGICAL

placebo

single dose IM

Sponsors & Collaborators

  • Public Health England

    collaborator OTHER_GOV

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Matt Hohenboken, MD, PhD · 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
2005-04-30
Primary Completion
2006-05-31
Completion
2006-08-31

Countries

  • United Kingdom

Study Locations

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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 NCT00211965 on ClinicalTrials.gov