Evaluation of Consistency of StaphVAX Manufacturing Lots
This study has been completed.
Sponsor:
Nabi Biopharmaceuticals
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
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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:
MedlinePlus related topics:
Staphylococcal Infections
Drug Information available for:
Staphylococcus aureus
U.S. FDA Resources
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
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 Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 17, 2013