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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00534248
First received: September 21, 2007
Last updated: September 6, 2013
Last verified: September 2013
Results First Received: January 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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
No text entered.

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  
Number of Participants  
[units: participants]
  11211     11228     22439  
Age  
[units: years]
Mean ± Standard Deviation
  54.9  ± 2.8     54.8  ± 2.8     54.8  ± 2.8  
Gender  
[units: participants]
     
Female     6,913     6,972     13885  
Male     4,298     4,256     8554  



  Outcome Measures
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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


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00534248     History of Changes
Other Study ID Numbers: V211-022, 2007_551
Study First Received: September 21, 2007
Results First Received: January 4, 2011
Last Updated: September 6, 2013
Health Authority: United States: Food and Drug Administration