Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00822237
First received: January 9, 2009
Last updated: October 1, 2014
Last verified: October 2014
Results First Received: October 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Varicella
Interventions: Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)

  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
VARIVAX 2007 Process + M-M-R II

VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart

M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart

VARIVAX 1999 Process + M-M-R II

VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart

M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart


Participant Flow for 2 periods

Period 1:   Dose 1 Vaccination
    VARIVAX 2007 Process + M-M-R II     VARIVAX 1999 Process + M-M-R II  
STARTED     299 [1]   299 [1]
COMPLETED     274     273  
NOT COMPLETED     25     26  
Not vaccinated                 3                 0  
Withdrawal by Subject                 13                 14  
Lost to Follow-up                 9                 12  
[1] Number randomized

Period 2:   Dose 2 Vaccination
    VARIVAX 2007 Process + M-M-R II     VARIVAX 1999 Process + M-M-R II  
STARTED     274 [1]   273 [1]
COMPLETED     270     262  
NOT COMPLETED     4     11  
Withdrawal by Subject                 2                 2  
Lost to Follow-up                 2                 9  
[1] Number who received second dose



  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
VARIVAX 2007 Process + M-M-R II

VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart

M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart

VARIVAX 1999 Process + M-M-R II

VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart

M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart

Total Total of all reporting groups

Baseline Measures
    VARIVAX 2007 Process + M-M-R II     VARIVAX 1999 Process + M-M-R II     Total  
Number of Participants  
[units: participants]
  299     299     598  
Age  
[units: months]
Mean ± Standard Deviation
  13.0  ± 1.83     13.0  ± 1.83     13.0  ± 1.83  
Gender  
[units: participants]
     
Female     158     138     296  
Male     141     161     302  



  Outcome Measures

1.  Primary:   Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).   [ Time Frame: 6 weeks following first 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 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: 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: NCT00822237     History of Changes
Other Study ID Numbers: V210-057, 2009_510
Study First Received: January 9, 2009
Results First Received: October 28, 2010
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration