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Evaluation of Consistency of StaphVAX Manufacturing Lots

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

September 13, 2005
September 21, 2005
May 14, 2012
April 2005
July 2005   (Final data collection date for primary outcome measure)
Type-specific antibody concentrations 6 weeks after vaccine dose.
Same as current
Complete list of historical versions of study NCT00211991 on ClinicalTrials.gov Archive Site
  • Antibody concentrations at other time points.
  • Elicited health events.
Same as current
Not Provided
Not Provided
 
Evaluation of Consistency of StaphVAX Manufacturing Lots
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Staphylococcal Infections
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
Not Provided
Creech CB 2nd, Johnson BG, Alsentzer AR, Hohenboken M, Edwards KM, Talbot TR 3rd. Vaccination as infection control: a pilot study to determine the impact of Staphylococcus aureus vaccination on nasal carriage. Vaccine. 2009 Dec 10;28(1):256-60. doi: 10.1016/j.vaccine.2009.09.088. Epub 2009 Sep 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
354
Same as current
July 2005
July 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00211991
Nabi-1369
Not Provided
Not Provided
Not Provided
Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
Vanderbilt University
Study Director: Matt Hohenboken, MD, PhD Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
May 2012

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