Evaluation of Consistency of StaphVAX Manufacturing Lots

Phase 3

Completed

• Conditions: Staphylococcal Infections

• Registration Number: NCT00211991
• Lead Sponsor: Nabi Biopharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Type-specific antibody concentrations 6 weeks after vaccine dose.

Secondary Outcome Measures

Name	Time	Method
Antibody concentrations at other time points.
Elicited health events.

Trial Locations

Locations (1)

Vanderbuilt University; 🇺🇸 Nashville, Tennessee, United States