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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00822237
First Posted: January 14, 2009
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: October 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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 
Overall Participants Analyzed 
[Units: Participants]
 299   299   598 
Age 
[Units: Months]
Mean (Standard Deviation)
 13.0  (1.83)   13.0  (1.83)   13.0  (1.83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      158  52.8%      138  46.2%      296  49.5% 
Male      141  47.2%      161  53.8%      302  50.5% 


  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
No text entered.


  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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00822237     History of Changes
Other Study ID Numbers: V210-057
2009_510
First Submitted: January 9, 2009
First Posted: January 14, 2009
Results First Submitted: October 28, 2010
Results First Posted: April 21, 2011
Last Update Posted: April 12, 2017