Evaluation of Manufacturing Lot of StaphVAX

December 26, 2007 updated by: Nabi Biopharmaceuticals

A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Madison, Alabama, United States, 35758
        • Trialogic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 8 wk of hemodialysis for ESRD,
  • have written informed consent,
  • a negative serum pregnancy test if appropriate,
  • and 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vaccine
single dose of StaphVAX in hemodialysis patients
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine
single IM dose totalling 200 mcg of conjugate
Other Names:
  • StaphVAX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type-specific antibody concentrations
Time Frame: 6 weeks after vaccine dose
6 weeks after vaccine dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Type-specific antibody concentrations
Time Frame: 3 weeks after vaccine dose
3 weeks after vaccine dose
Elicited vaccine reactogenicity.
Time Frame: daily for 7 days after dose
daily for 7 days after dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabi Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

November 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2008

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nabi-1367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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