Evaluation of Consistency of StaphVAX Manufacturing Lots

Phase 3CompletedNCT00211991

Nabi Biopharmaceuticals354 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

354

Conditions

Staphylococcal Infections

Interventions

S. aureus Type 5 & 8 Capsular Polysaccharide ConjugateBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vanderbuilt University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Type-specific antibody concentrations 6 weeks after vaccine dose.

Secondary Outcomes

Antibody concentrations at other time points.

Elicited health events.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.