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A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01077804
First received: February 26, 2010
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
Results First Received: September 29, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Varicella
Herpes Zoster

  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
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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
Varivax Vaccinated Children Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.

Participant Flow:   Overall Study
    Varivax Vaccinated Children  
STARTED     7585  
COMPLETED     7386  
NOT COMPLETED     199  
Unreachable                 102  
Refused to continue                 79  
Other                 18  



  Baseline Characteristics
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Reporting Groups
  Description
Varivax Vaccinated Children Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.

Baseline Measures
    Varivax Vaccinated Children  
Number of Participants  
[units: participants]
 		  7585  
Age, Customized  
[units: Participants]
 		 
12-23 months     7585  
Gender  
[units: participants]
 		 
Female     3714  
Male     3871  
Region of Enrollment  
[units: participants]
 		 
United States     7585  



  Outcome Measures
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1.  Primary:   Number of Participants With an Occurrence of Breakthrough Varicella   [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ]
  Show Outcome Measure 1

2.  Primary:   Incidence Rate of Breakthrough Varicella   [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With an Occurrence of Herpes Zoster Infection   [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ]
  Show Outcome Measure 3

4.  Secondary:   Incidence Rate of Herpes Zoster Infection   [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


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


Publications:


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01077804     History of Changes
Other Study ID Numbers: V210-036, 2010_014
Study First Received: February 26, 2010
Results First Received: September 29, 2011
Last Updated: September 29, 2011
Health Authority: United States: Institutional Review Board