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Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00735839 |
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 |
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 |
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
|
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections Healthy |
Infection |