Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00572910
First received: December 11, 2007
Last updated: March 16, 2015
Last verified: March 2015
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Prevention
Condition: Staphylococcus Aureus Infection
Interventions: Biological: Comparator: Placebo (PBO)
Biological: V710 Comparator: Placebo (PBO)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide 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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: 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: March 16, 2015