Evaluation of Consistency of StaphVAX Manufacturing Lots - Full Text View

Evaluation of Consistency of StaphVAX Manufacturing Lots

This study has been completed.

Sponsors and Collaborators:	Nabi Biopharmaceuticals Vanderbilt University
Information provided by:	Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00211991

Purpose

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.

Condition	Intervention	Phase
Staphylococcal Infections	Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate	Phase III

MedlinePlus related topics:

Staphylococcal Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:

Type-specific antibody concentrations 6 weeks after vaccine dose.

Secondary Outcome Measures:

Antibody concentrations at other time points.
Elicited health events.

Estimated Enrollment:	354
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211991

Locations


United States, Tennessee
	Vanderbuilt University
	Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Nabi Biopharmaceuticals

Vanderbilt University

Investigators


Study Director:	Matt Hohenboken, MD, PhD	Nabi Biopharmaceuticals

More Information

Study ID Numbers:	Nabi-1369
First Received:	September 13, 2005
Last Updated:	July 7, 2006
ClinicalTrials.gov Identifier:	NCT00211991
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections

Staphylococcal Infections

Gram-Positive Bacterial Infections

Healthy

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 03, 2008