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StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00211965
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 4, 2008
Information provided by:

September 13, 2005
September 21, 2005
January 4, 2008
April 2005
May 2006   (Final data collection date for primary outcome measure)
Sero-type specific antibody concentrations [ Time Frame: 6 weeks after study dose ]
Sero-type specific antibody concentrations 6 weeks after study dose.
Complete list of historical versions of study NCT00211965 on ClinicalTrials.gov Archive Site
  • Sero-type specific antibody concentrations [ Time Frame: various other time points after study dose, up to 26 wk ]
  • adverse events [ Time Frame: throughout 6 months observation after study dose ]
  • Sero-type specific antibody concentrations at other time points after study dose.
  • Safety.
Not Provided
Not Provided
StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adult Patients Receiving an Orthopedic Prosthetic Implant
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Staphylococcal Infections
  • Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
    single IM dose of 200 mcg total conjugate
    Other Name: StaphVAX®
  • Biological: placebo
    single dose IM
  • Experimental: vaccine
    single dose
    Intervention: Biological: S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
  • Placebo Comparator: placebo
    single dose
    Intervention: Biological: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2006
May 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older
  • Candidate for knee or hip replacement
  • Expectation of protocol compliance
  • Negative pregnancy test, where appropriate

Exclusion Criteria:

  • Known S. aureus infection in the prior 3 months
  • Infection in the prior 2 weeks
  • Known HIV infection
  • Immunomodulatory drugs
  • Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early prostate cancer)
  • Hypersensitivity to components of StaphVAX
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs, Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
Public Health England
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP