Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Colorado, Denver
Duke University
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01245751
First received: November 19, 2010
Last updated: February 13, 2014
Last verified: February 2014
Results First Received: April 10, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Herpes Zoster
Intervention: Biological: Zoster Vaccine, Live

  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
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
Group 1: Booster Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study (NCT00007501)
Group 2: First Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age
Group 3: First Dose Participants ≥60 and <70 Years of Age Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live
Group 4: First Dose Participants ≥50 and <60 Years of Age Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live

Participant Flow:   Overall Study
    Group 1: Booster Dose Participants ≥70 Years of Age     Group 2: First Dose Participants ≥70 Years of Age     Group 3: First Dose Participants ≥60 and <70 Years of Age     Group 4: First Dose Participants ≥50 and <60 Years of Age  
STARTED     201     199     100     100  
Completed 42-day Postvaccination Period     201     199     100     100  
COMPLETED     0 [1]   0 [1]   0 [1]   0 [1]
NOT COMPLETED     201     199     100     100  
Ongoing safety follow-up                 201                 199                 100                 100  
[1] Participants will complete the study after a 1-year postvaccination follow-up visit



  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.
No text entered.

Reporting Groups
  Description
Group 1: Booster Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study (NCT00007501)
Group 2: First Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age
Group 3: First Dose Participants ≥60 and <70 Years of Age Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live
Group 4: First Dose Participants ≥50 and <60 Years of Age Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live
Total Total of all reporting groups

Baseline Measures
    Group 1: Booster Dose Participants ≥70 Years of Age     Group 2: First Dose Participants ≥70 Years of Age     Group 3: First Dose Participants ≥60 and <70 Years of Age     Group 4: First Dose Participants ≥50 and <60 Years of Age     Total  
Number of Participants  
[units: participants]
  201     199     100     100     600  
Age  
[units: years]
Mean ± Standard Deviation
  77.1  ± 4.5     76.3  ± 5.1     64.1  ± 3.1     55.5  ± 2.8     71.1  ± 9.4  
Gender  
[units: participants]
         
Female     107     94     65     77     343  
Male     94     105     35     23     257  



  Outcome Measures
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1.  Primary:   Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)   [ Time Frame: Week 6 postvaccination ]

2.  Primary:   Geometric Mean Fold Rise (GMFR) From Day 1 to Week 6 Postvaccination in VZV Antibody Titers   [ Time Frame: Day 1 and Week 6 postvaccination ]

3.  Secondary:   Number of Participants Reporting One or More Adverse Experiences   [ Time Frame: Up to 42 days postvaccination ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01245751     History of Changes
Other Study ID Numbers: V211-029
Study First Received: November 19, 2010
Results First Received: April 10, 2013
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration