Evaluation of Consistency of StaphVAX Manufacturing Lots

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. Identifier: NCT00211991
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 14, 2012
Vanderbilt University
Information provided by (Responsible Party):
Nabi Biopharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Staphylococcal Infections Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers
Study Start Date : April 2005
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Type-specific antibody concentrations 6 weeks after vaccine dose.

Secondary Outcome Measures :
  1. Antibody concentrations at other time points.
  2. Elicited health events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy,
  • written informed consent,
  • negative serum pregnancy test if appropriate,
  • expect to comply with protocol procedures and schedule

Exclusion Criteria:

  • known HIV,
  • immunomodulatory drugs,
  • malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
  • active infection in the 2 weeks prior to study injection,
  • serious S. aureus infection within the last 3 months prior to injection,
  • use of investigational drugs, vaccines or devices within the prior 30 days,
  • hypersensitivity to components of StaphVAX

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00211991

United States, Tennessee
Vanderbuilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Nabi Biopharmaceuticals
Vanderbilt University
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nabi Biopharmaceuticals Identifier: NCT00211991     History of Changes
Other Study ID Numbers: Nabi-1369
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections