Evaluation of Consistency of StaphVAX Manufacturing Lots

Nabi Biopharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Staphylococcal Infections

Treatments

Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00211991

Nabi-1369

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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