Evaluation of Consistency of StaphVAX Manufacturing Lots

Staphylococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211991
• Other study ID #: Nabi-1369
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 10, 2012
• Start date: April 2005
• Est. completion date: July 2005

Study information

• Verified date: May 2012
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Staphylococcal Infections

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbuilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals	Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type-specific antibody concentrations 6 weeks after vaccine dose.
Secondary	Antibody concentrations at other time points.
Secondary	Elicited health events.