Evaluation of Manufacturing Lot of StaphVAX

A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00211900

Enrollment

Registered

2005-09-21

Start date

2005-03-31

Completion date

2005-11-30

Last updated

2008-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure, Staphylococcal Infections

Brief summary

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.

Interventions

BIOLOGICALS. aureus Type 5 & 8 Capsular Polysaccharide Vaccine

single IM dose totalling 200 mcg of conjugate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Type-specific antibody concentrations	6 weeks after vaccine dose

Secondary

Measure	Time frame
Type-specific antibody concentrations	3 weeks after vaccine dose
Elicited vaccine reactogenicity.	daily for 7 days after dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026