Evaluation of Consistency of StaphVAX Manufacturing Lots

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

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Staphylococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* healthy,
* written informed consent,
* negative serum pregnancy test if appropriate,
* 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

Yes