A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00572910
First received: December 11, 2007
Last updated: August 9, 2013
Last verified: August 2013
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Staphylococcus Aureus Infection
Interventions: Biological: Comparator: Placebo (PBO)
Biological: V710 Comparator: Placebo (PBO)

  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 (60 Mcg / 60 Mcg / 60 Mcg) Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
V710 (60 Mcg / 60 Mcg / PBO) Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
V710 (60 Mcg / PBO / 60 Mcg) Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
V710 (60 Mcg / PBO / PBO) Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
V710 (60 Mcg / 60 Mcg / 60 Mcg) + MAA Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
V710 (60 Mcg / 60 Mcg / PBO) + MAA Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg /PBO) with MAA.
V710 (60 Mcg / PBO / 60 Mcg) + MAA Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
V710 (60 Mcg / PBO / PBO) + MAA Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
V710 (90 Mcg / 90 Mcg / 90 Mcg) + MAA Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
V710 (90 Mcg / 90 Mcg / PBO) + MAA Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
Placebo (PBO / PBO / PBO) Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).

Participant Flow:   Overall Study
    V710 (60 Mcg / 60 Mcg / 60 Mcg)     V710 (60 Mcg / 60 Mcg / PBO)     V710 (60 Mcg / PBO / 60 Mcg)     V710 (60 Mcg / PBO / PBO)     V710 (60 Mcg / 60 Mcg / 60 Mcg) + MAA     V710 (60 Mcg / 60 Mcg / PBO) + MAA     V710 (60 Mcg / PBO / 60 Mcg) + MAA     V710 (60 Mcg / PBO / PBO) + MAA     V710 (90 Mcg / 90 Mcg / 90 Mcg) + MAA     V710 (90 Mcg / 90 Mcg / PBO) + MAA     Placebo (PBO / PBO / PBO)  
STARTED     19     18     19     18     19     19     19     19     19     19     18  
COMPLETED     15     15     17     14     17     16     15     15     16     13     15  
NOT COMPLETED     4     3     2     4     2     3     4     4     3     6     3  
Adverse Event                 1                 2                 0                 2                 0                 0                 4                 2                 1                 3                 2  
Lost to Follow-up                 0                 1                 1                 2                 1                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 3                 0                 1                 0                 1                 3                 0                 2                 2                 2                 1  



  Baseline Characteristics
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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
  Description
V710 (60 Mcg / 60 Mcg) Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
V710 (60 Mcg / PBO) Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28.
V710 (60 Mcg / 60 Mcg) + MAA Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
V710 (60 Mcg / PBO) + MAA Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28.
V710 (90 Mcg / 90 Mcg) + MAA Participants who were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
Placebo (PBO / PBO) Participants who were vaccinated with Placebo on Day 1 and Day 28.
Total Total of all reporting groups

Baseline Measures
    V710 (60 Mcg / 60 Mcg)     V710 (60 Mcg / PBO)     V710 (60 Mcg / 60 Mcg) + MAA     V710 (60 Mcg / PBO) + MAA     V710 (90 Mcg / 90 Mcg) + MAA     Placebo (PBO / PBO)     Total  
Number of Participants  
[units: participants]
  37     37     38     38     38     18     206  
Age, Customized  
[units: Participants]
             
<50 years of age     10     14     14     5     14     6     63  
>=50 years of age     27     23     24     33     24     12     143  
Gender  
[units: participants]
             
Female     13     15     19     14     16     7     84  
Male     24     22     19     24     22     11     122  



  Outcome Measures
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1.  Primary:   Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination   [ Time Frame: Prevaccination to 56 days postvaccination ]

2.  Primary:   Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)   [ Time Frame: Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths. ]

3.  Secondary:   GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination   [ Time Frame: Prevaccination to 28 days postvaccination ]

4.  Secondary:   GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination   [ Time Frame: Prevaccination to 180 days postvaccination ]

5.  Secondary:   GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination   [ Time Frame: Prevaccination to 56 days postvaccination ]

6.  Secondary:   GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints   [ Time Frame: Prevaccination to 360 days post vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00572910     History of Changes
Other Study ID Numbers: V710-005, 2007_609
Study First Received: December 11, 2007
Results First Received: July 20, 2011
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration