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

This study has been completed.
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: March 24, 2016
Last verified: March 2016
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
Conditions: Herpes Zoster
Varicella-zoster Vaccine
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
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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 V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
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. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
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. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
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. Participants received a single Zoster Vaccine, Live vaccination on Day 1.

Participant Flow for 2 periods

Period 1:   Part 1: Day 1 to Week 52 (1 Year)
    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   199   194   100   98 
NOT COMPLETED   2   5   0   2 
Death                2                1                0                0 
Lost to Follow-up                0                0                0                2 
Withdrawal by Subject                0                4                0                0 

Period 2:   Part 2: Week 156 (3 Year) Visit
    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   161 [1]   139 [1]   0 [2]   0 [2] 
COMPLETED   161   139   0   0 
NOT COMPLETED   0   0   0   0 
[1] Enrollment in Part 2 was voluntary
[2] Part 2 was planned for Groups 1 and 2 only



  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 V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
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. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
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. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
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. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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

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


  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 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.


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: NCT01245751     History of Changes
Other Study ID Numbers: V211-029
Study First Received: November 19, 2010
Results First Received: April 10, 2013
Last Updated: March 24, 2016
Health Authority: United States: Food and Drug Administration