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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00735839
First received: August 13, 2008
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
Results First Received: May 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Staphylococcal Infection
Interventions: Biological: V710
Biological: Placebo

  Participant Flow
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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
  Description
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  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
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  
Number of Participants  
[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  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     30     10     40  



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

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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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Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00735839     History of Changes
Other Study ID Numbers: V710-006, 2008_017
Study First Received: August 13, 2008
Results First Received: May 23, 2012
Last Updated: May 23, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency