Evaluation of Consistency of StaphVAX Manufacturing Lots

Completed · Phase 3

Conditions studied: Staphylococcal Infections

In brief

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.

Key facts

Study ID

NCT00211991

Run by

Nabi Biopharmaceuticals

People needed

354

Starts

2005-04-01

Expected to finish

2005-07-01

Last updated by the study team

2012-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy,
• written informed consent,
• negative serum pregnancy test if appropriate,
• expect to comply with protocol procedures and schedule

You may not qualify if…

• 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

Where it is running

• Vanderbuilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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