Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly
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ClinicalTrials.gov Identifier: NCT01331161 |
Recruitment Status :
Completed
First Posted : April 7, 2011
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
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Sponsor:
Emory University
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Nadine Rouphael, Emory University
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science |
Condition |
Shingles |
Intervention |
Biological: ZOSTAVAX |
Enrollment | 77 |
Participant Flow
Recruitment Details | Subjects were recruited from Atlanta and Denver from July 2011 until March 2012 using flyers |
Pre-assignment Details |
Arm/Group Title | Older Group | Younger Group |
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Participants between the ages of 60-79 ZOSTAVAX: shingles vaccine, one dose |
Participants between the ages of 25-40 ZOSTAVAX: shingles vaccine, one dose |
Period Title: Overall Study | ||
Started | 44 | 33 |
Completed | 43 | 31 |
Not Completed | 1 | 2 |
Reason Not Completed | ||
Physician Decision | 1 | 0 |
Lost to Follow-up | 0 | 1 |
Pregnancy | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Age 60-79 Years | Age 25-40 Years | Total | |
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Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously. | Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously. | Total of all reporting groups | |
Overall Number of Baseline Participants | 44 | 33 | 77 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | 33 participants | 77 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
20 45.5%
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33 100.0%
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53 68.8%
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>=65 years |
24 54.5%
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0 0.0%
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24 31.2%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 44 participants | 33 participants | 77 participants | |
68
(60 to 77)
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33
(25 to 40)
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61
(25 to 77)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | 33 participants | 77 participants | |
Female |
25 56.8%
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23 69.7%
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48 62.3%
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Male |
19 43.2%
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10 30.3%
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29 37.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 44 participants | 33 participants | 77 participants |
44 | 33 | 77 | ||
Ethnicity
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 44 participants | 33 participants | 77 participants |
Hispanic | 3 | 3 | 6 | |
Non hispanic | 41 | 30 | 71 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Nadine Rouphael, MD |
Organization: | Emory University |
Phone: | 404-712-1435 |
EMail: | nroupha@emory.edu |
Responsible Party: | Nadine Rouphael, Emory University |
ClinicalTrials.gov Identifier: | NCT01331161 |
Other Study ID Numbers: |
IRB00050285 U19AI090023 ( U.S. NIH Grant/Contract ) HIPCVAX005 ( Other Identifier: Other ) |
First Submitted: | April 6, 2011 |
First Posted: | April 7, 2011 |
Results First Submitted: | January 19, 2016 |
Results First Posted: | February 17, 2016 |
Last Update Posted: | February 17, 2016 |