NCT00130260

Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease

Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.

Conditions

• Staphylococcal Infections
• Chronic Kidney Failure

Interventions

Type	Name	Description
BIOLOGICAL	Staph aureus types 5 and 8 conjugate vaccine	each IM dose contains 200 mc total conjugate
BIOLOGICAL	placebo	placebo to match StaphVAX

Timeline

• Start date: 2005-08-01
• Primary completion: 2005-12-01
• Completion: 2006-04-01
• First posted: 2005-08-15
• Last updated: 2008-01-04

Locations

1 site across 1 country: United States