MedTrace Logo

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

NCT00130260 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2008-01-04

No results posted yet for this study

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

BIOLOGICAL

Staph aureus types 5 and 8 conjugate vaccine

each IM dose contains 200 mc total conjugate

BIOLOGICAL

placebo

placebo to match StaphVAX

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Matt Hohenboken, MD, PhD · Nabi Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2005-12-31
Completion
2006-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00130260 on ClinicalTrials.gov