V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00735839
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : June 26, 2012
Last Update Posted : December 21, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Staphylococcal Infection
Interventions: Biological: V710
Biological: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
V710 V710 vaccination (60 mcg) single dose on Day 1
Placebo Placebo single dose on Day 1

Participant Flow:   Overall Study
    V710   Placebo
STARTED   30   10 
COMPLETED   30   10 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
V710 V710 vaccination (60 mcg) single dose on Day 1
Placebo Placebo single dose on Day 1
Total Total of all reporting groups

Baseline Measures
   V710   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   10   40 
Age, Customized 
[Units: Participants]
<20 years   0   0   0 
20-74 years   30   10   40 
>74 years   0   0   0 
[Units: Participants]
Female   0   0   0 
Male   30   10   40 

  Outcome Measures

1.  Primary:   Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level   [ Time Frame: Baseline (Day 1) to Day 14 postvaccination ]

2.  Primary:   Number of Participants With Vaccine-related Serious Adverse Experiences   [ Time Frame: Baseline (Day 1) to Day 84 postvaccination ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00735839     History of Changes
Other Study ID Numbers: V710-006
First Submitted: August 13, 2008
First Posted: August 15, 2008
Results First Submitted: May 23, 2012
Results First Posted: June 26, 2012
Last Update Posted: December 21, 2015