Trials / Completed
CompletedNCT00211991
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 354 (planned)
- Sponsor
- Nabi Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2005-07-01
- Completion
- 2005-07-01
- First posted
- 2005-09-21
- Last updated
- 2012-05-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00211991. Inclusion in this directory is not an endorsement.