Back to resultsEvaluation of Consistency of StaphVAX Manufacturing Lots
Primary Purpose
Staphylococcal Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcal Infections
Eligibility 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
Sites / Locations
- Vanderbuilt University
Outcomes
Primary Outcome Measures
Type-specific antibody concentrations 6 weeks after vaccine dose.
Secondary Outcome Measures
Antibody concentrations at other time points.
Elicited health events.
Full Information
NCT ID
NCT00211991
First Posted
September 13, 2005
Last Updated
May 10, 2012
Sponsor
Nabi Biopharmaceuticals
Collaborators
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT00211991
Brief Title
Evaluation of Consistency of StaphVAX Manufacturing Lots
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nabi Biopharmaceuticals
Collaborators
Vanderbilt University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
354 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
Primary Outcome Measure Information:
Title
Type-specific antibody concentrations 6 weeks after vaccine dose.
Secondary Outcome Measure Information:
Title
Antibody concentrations at other time points.
Title
Elicited health events.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Hohenboken, MD, PhD
Organizational Affiliation
Nabi Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbuilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19799842
Citation
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.
Results Reference
derived
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Evaluation of Consistency of StaphVAX Manufacturing Lots
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