Evaluation of Manufacturing Lot of StaphVAX

NCT ID: NCT00211900

Last Updated: 2008-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Staphylococcal Infections Chronic Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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vaccine

single dose of StaphVAX in hemodialysis patients

Group Type EXPERIMENTAL

S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine

Intervention Type BIOLOGICAL

single IM dose totalling 200 mcg of conjugate

Interventions

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S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine

single IM dose totalling 200 mcg of conjugate

Intervention Type BIOLOGICAL

Other Intervention Names

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StaphVAX®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nabi Biopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Nabi Biopharmaceuticals

Principal Investigators

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Matt Hohenboken, MD, PhD

Role: STUDY_DIRECTOR

Nabi Biopharmaceuticals

Locations

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Trialogic Research

Madison, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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Nabi-1367

Identifier Type: -

Identifier Source: org_study_id

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