V710 Phase I Study in Healthy Male Japanese Subjects - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00735839

Purpose

This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.

Condition	Intervention	Phase
Staphylococcal Infection	Biological: V710 Biological: Comparator: Placebo (unspecified)	Phase I

MedlinePlus related topics: Staphylococcal Infections

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, Tolerability, and Immunogenicity of a Single Dose of Merck S. Aureus Vaccine (V710) in Healthy Male Japanese Subjects

Further study details as provided by Merck:

Primary Outcome Measures:

Change in Antibody level from baseline as measured at 5 predefined time points. [ Time Frame: Time Frame: 84 Days ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	March 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: V710 V710 0.5ml single injection.
2: Placebo Comparator	Biological: Comparator: Placebo (unspecified) Placebo 0.5ml single injection

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before
Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735839

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:	2008_017, V710-006
Study First Received:	August 13, 2008
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00735839
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Healthy

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009