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Evaluation of Consistency of StaphVAX Manufacturing Lots

This study has been completed.
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00211991
First received: September 13, 2005
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Staphylococcal Infections
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

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

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

Estimated Enrollment: 354
Study Start Date: April 2005
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211991

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

No publications provided by Nabi Biopharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00211991     History of Changes
Other Study ID Numbers: Nabi-1369
Study First Received: September 13, 2005
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014