Evaluation of Manufacturing Lot of StaphVAX

Phase 3CompletedNCT00211900

Nabi Biopharmaceuticals65 enrolled

Overview

This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Staphylococcal Infections Chronic Kidney Failure

Interventions

S. aureus Type 5 & 8 Capsular Polysaccharide VaccineBIOLOGICAL

single IM dose totalling 200 mcg of conjugate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 8 wk of hemodialysis for ESRD, * have written informed consent, * a negative serum pregnancy test if appropriate, * and 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)

Trialogic Research

Madison, Alabama, United States

Outcomes

Primary Outcomes

Type-specific antibody concentrations

Time frame: 6 weeks after vaccine dose

Secondary Outcomes

Type-specific antibody concentrations

Time frame: 3 weeks after vaccine dose

Elicited vaccine reactogenicity.

Time frame: daily for 7 days after dose

Data from ClinicalTrials.gov

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