A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis - Full Text View

Purpose

This is a study to evaluate the safety and immunogenicity of V710 in patients with end-stage kidney disease on hemodialysis.

Condition	Intervention	Phase
Staphylococcus Aureus	Biological: V710 Biological: Comparator: Placebo (unspecified)	Phase II

MedlinePlus related topics:

Dialysis Kidney Failure

Drug Information available for:

Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Merck Staphylococcus Aureus Vaccine (V710) in Adult Patients With End-Stage Renal Disease on Chronic Hemodialysis

Further study details as provided by Merck:

Primary Outcome Measures:

Change in Antibody level from baseline as measured at 8 predefined time points. [ Time Frame: 360 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	198
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Group 1: V710 (60 μg without MAA) on Day 1 and Day 28	Biological: V710 V710 (60 μg without MAA),(60 μg with MAA), (90 μg with MAA); Duration of Treatment 1 Year.
2: Experimental Group 2: V710 (60 μg without MAA) on Day 1, followed by saline placebo on Day 28	Biological: Comparator: Placebo (unspecified) saline placebo; Duration of Treatment 1 Years
3: Experimental Group 3: V710 (60 μg with MAA) on Day 1 and Day 28	Biological: V710 V710 (60 μg without MAA),(60 μg with MAA), (90 μg with MAA); Duration of Treatment 1 Year.
4: Experimental Group 4: V710 (60 μg with MAA) on Day 1, followed by saline placebo on Day 28	Biological: Comparator: Placebo (unspecified) saline placebo; Duration of Treatment 1 Years
5: Experimental Group 5: V710 (90 μg with MAA) on Day 1 and Day 28	Biological: V710 V710 (60 μg without MAA),(60 μg with MAA), (90 μg with MAA); Duration of Treatment 1 Year.
6: Placebo Comparator Group 6: Saline placebo on Day 1 and Day 28	Biological: Comparator: Placebo (unspecified) saline placebo; Duration of Treatment 1 Years

Eligibility

Criteria

Inclusion Criteria:

Diagnosed with end stage kidney disease and is on hemodialysis
Female patients who are able to have children must have a negative urine pregnancy tests

Exclusion Criteria:

Developed a serious infection within the past 12 months
Allergy to the components of the vaccine
Has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days
Received V710 vaccine before

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572910

Contacts


Contact: Toll Free Number	1-888-577-8839

Locations


United States, California
	Call for Information	Recruiting
	West Hills, California, United States, 91307

United States, Florida
	Call for Information	Recruiting
	Miami, Florida, United States, 33173
	Call for Information	Recruiting
	Miami, Florida, United States, 33143

United States, Hawaii
	Call for Information	Recruiting
	Honolulu, Hawaii, United States, 96817

United States, Kentucky
	Call for Information	Recruiting
	Louisville, Kentucky, United States, 40202

United States, New Jersey
	Call for Information	Recruiting
	Paterson, New Jersey, United States, 07503

United States, New York
	Call for Information	Recruiting
	Orchard Park, New York, United States, 14127

United States, South Carolina
	Call for Information	Recruiting
	Orangeburg, South Carolina, United States, 29115
	Call for Information	Recruiting
	Columbia, South Carolina, United States, 29203

United States, Tennessee
	Call for Information	Recruiting
	Chattanooga, Tennessee, United States, 37404

United States, Virginia
	Call for Information	Recruiting
	Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_609, V710-005
First Received:	December 11, 2007
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00572910
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Kidney Failure, Chronic

Kidney Diseases

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00572910