Back to resultsV710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
Primary Purpose
Staphylococcal Infection
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V710
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcal Infection
Eligibility Criteria
Inclusion Criteria:
- Generally Good Physical Health
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
V710
Placebo
Arm Description
V710 vaccination (60 mcg) single dose on Day 1
Placebo single dose on Day 1
Outcomes
Primary Outcome Measures
Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level
Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.
Number of Participants With Vaccine-related Serious Adverse Experiences
Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.
Secondary Outcome Measures
Full Information
NCT ID
NCT00735839
First Posted
August 13, 2008
Last Updated
December 18, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00735839
Brief Title
V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V710
Arm Type
Experimental
Arm Description
V710 vaccination (60 mcg) single dose on Day 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo single dose on Day 1
Intervention Type
Biological
Intervention Name(s)
V710
Intervention Description
V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline placebo (0.5 ml) single injection on Day 1
Primary Outcome Measure Information:
Title
Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level
Description
Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.
Time Frame
Baseline (Day 1) to Day 14 postvaccination
Title
Number of Participants With Vaccine-related Serious Adverse Experiences
Description
Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.
Time Frame
Baseline (Day 1) to Day 84 postvaccination
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Generally Good Physical Health
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
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