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Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00534248
First Posted: September 24, 2007
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: January 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Shingles
Interventions: Biological: Zoster Vaccine, Live (Zostavax™)
Biological: Comparator: Placebo

  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
Zostavax™ Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
Placebo Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.

Participant Flow:   Overall Study
    Zostavax™   Placebo
STARTED   11211   11228 
VACCINATED   11186   11210 
COMPLETED   10550   10555 
NOT COMPLETED   661   673 
Adverse Event                19                29 
Lost to Follow-up                353                375 
Other protocol specified criteria                13                3 
Physician Decision                10                7 
Protocol Violation                3                4 
Withdrawal by Subject                263                255 



  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
Zostavax™ Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
Placebo Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Total Total of all reporting groups

Baseline Measures
   Zostavax™   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 11211   11228   22439 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.9  (2.8)   54.8  (2.8)   54.8  (2.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6913  61.7%      6972  62.1%      13885  61.9% 
Male      4298  38.3%      4256  37.9%      8554  38.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group   [ Time Frame: 2 Years ]

2.  Secondary:   Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group   [ Time Frame: 6 Weeks ]

3.  Secondary:   Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period   [ Time Frame: Through 42 days post-vaccination ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00534248     History of Changes
Other Study ID Numbers: V211-022
2007_551
First Submitted: September 21, 2007
First Posted: September 24, 2007
Results First Submitted: January 4, 2011
Results First Posted: May 2, 2011
Last Update Posted: April 12, 2017