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Zoster Vaccine Response in the Frail Elderly

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mark Loeb, McMaster University
ClinicalTrials.gov Identifier:
NCT01328548
First received: March 15, 2011
Last updated: March 3, 2017
Last verified: March 2017
Results First Received: March 3, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Control;   Time Perspective: Prospective
Condition: Immune System Diseases
Intervention: Drug: Zostavax

  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
Nursing Home Vaccine Group Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
Community Control Vaccine Group Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine

Participant Flow:   Overall Study
    Nursing Home Vaccine Group   Community Control Vaccine Group
STARTED   191   50 
COMPLETED   187   50 
NOT COMPLETED   4   0 
Death                3                0 
Protocol Violation                1                0 



  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
Nursing Home Vaccine Group Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
Community Control Vaccine Group Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
Total Total of all reporting groups

Baseline Measures
   Nursing Home Vaccine Group   Community Control Vaccine Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 191   50   241 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      15  30.0%      15   6.2% 
>=65 years      191 100.0%      35  70.0%      226  93.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 89.0  (4.69)   67.3  (4.34)   84.5  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      154  80.6%      32  64.0%      186  77.2% 
Male      37  19.4%      18  36.0%      55  22.8% 
Region of Enrollment 
[Units: Participants]
     
Canada   191   50   241 


  Outcome Measures
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1.  Primary:   Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly   [ Time Frame: 6 weeks ]

2.  Primary:   Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio   [ Time Frame: Baseline ]

3.  Primary:   Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells   [ Time Frame: Baseline ]

4.  Other Pre-specified:   Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells   [ Time Frame: Baseline ]

5.  Other Pre-specified:   Assessment of Immune Parameters Compatible With Inflammaging: High CD8+CD28CD45RA+T Cells   [ Time Frame: Baseline ]

6.  Other Pre-specified:   Testing 150 Candidate Immune Response Genes for SNP Analysis   [ Time Frame: Baseline ]

7.  Other Pre-specified:   Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Dr. Mark Loeb
Organization: McMaster University
phone: 905 515 9140 ext 26679
e-mail: loebm@mcmaster.ca


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mark Loeb, McMaster University
ClinicalTrials.gov Identifier: NCT01328548     History of Changes
Other Study ID Numbers: 09-450
Study First Received: March 15, 2011
Results First Received: March 3, 2016
Last Updated: March 3, 2017