Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01536405
First received: February 16, 2012
Last updated: May 30, 2014
Last verified: May 2014
Results First Received: May 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Measles
Mumps
Rubella
Varicella
Interventions: Biological: MMRV (AMP)
Biological: MMRV (2006 process)

  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
One participant was inadvertently randomized twice, for a total of 1413 randomizations. The Participant Flow reported below includes this participant only once.

Reporting Groups
  Description
MMRV (AMP) Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
MMRV (2006 Process) Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Participant Flow for 5 periods

Period 1:   Randomization to Visit 1 (Vaccination 1)
    MMRV (AMP)     MMRV (2006 Process)  
STARTED     706     706  
COMPLETED     698     702  
NOT COMPLETED     8     4  
Not vaccinated                 8                 4  

Period 2:   Visit 1 (Vaccination 1) to Visit 2
    MMRV (AMP)     MMRV (2006 Process)  
STARTED     698     702  
Received Vaccination 1     698     702  
COMPLETED     666     662  
NOT COMPLETED     32     40  
Withdrawal by Subject                 12                 18  
Lost to Follow-up                 20                 22  

Period 3:   Visit 2 to Visit 3 (Vaccination 2)
    MMRV (AMP)     MMRV (2006 Process)  
STARTED     666     662  
COMPLETED     635     634  
NOT COMPLETED     31     28  
Withdrawal by Subject                 17                 13  
Adverse Event                 3                 3  
Lost to Follow-up                 9                 10  
Protocol Violation                 2                 2  

Period 4:   Visit 3 (Vaccination 2) to Visit 4
    MMRV (AMP)     MMRV (2006 Process)  
STARTED     635     634  
Received Vaccination 2     634     632  
COMPLETED     615     618  
NOT COMPLETED     20     16  
Withdrawal by Subject                 3                 2  
Adverse Event                 1                 0  
Lost to Follow-up                 16                 14  

Period 5:   Visit 4 to Extended Study Follow-up
    MMRV (AMP)     MMRV (2006 Process)  
STARTED     615     618  
COMPLETED     595     595  
NOT COMPLETED     20     23  
Withdrawal by Subject                 0                 2  
Adverse Event                 0                 1  
Lost to Follow-up                 20                 20  



  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
MMRV (AMP) Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
MMRV (2006 Process) Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
Total Total of all reporting groups

Baseline Measures
    MMRV (AMP)     MMRV (2006 Process)     Total  
Number of Participants  
[units: participants]
  706     706     1412  
Age  
[units: Months]
Mean ± Standard Deviation
  13.4  ± 2.2     13.6  ± 2.5     13.5  ± 2.3  
Gender  
[units: Participants]
     
Female     344     324     668  
Male     362     382     744  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL   [ Time Frame: Six weeks after vaccination 1 ]

2.  Primary:   Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL   [ Time Frame: Six weeks after vaccination 1 ]

3.  Primary:   Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL   [ Time Frame: Six weeks after vaccination 1 ]

4.  Primary:   Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)   [ Time Frame: Six weeks after vaccination 1 ]

5.  Primary:   Geometric Mean Titer (GMT) of VZV Antibodies   [ Time Frame: Six weeks after vaccination 1 ]

6.  Primary:   Geometric Mean Titer (GMT) of Measles Virus Antibodies   [ Time Frame: Six weeks after vaccination 1 ]

7.  Primary:   Geometric Mean Titer (GMT) of Mumps Virus Antibodies   [ Time Frame: Six weeks after vaccination 1 ]

8.  Primary:   Geometric Mean Titer (GMT) of Rubella Virus Antibodies   [ Time Frame: Six weeks after vaccination 1 ]

9.  Primary:   Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)   [ Time Frame: Up to 5 days after vaccination 1 ]

10.  Secondary:   Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)   [ Time Frame: Up to 42 days after each vaccination ]

11.  Secondary:   Percentage of Participants With Zoster-like Rash   [ Time Frame: Up to 42 days after each vaccination ]

12.  Secondary:   Percentage of Participants With Mumps-like Symptoms   [ Time Frame: Up to 42 days after each vaccination ]

13.  Secondary:   Percentage of Participants With Measles-like Rash   [ Time Frame: Up to 42 days after each vaccination ]

14.  Secondary:   Percentage of Participants With Rubella-like Rash   [ Time Frame: Up to 42 days after each vaccination ]

15.  Secondary:   Percentage of Participants With Varicella-like Rash   [ Time Frame: Up to 42 days after each vaccination ]

16.  Secondary:   Percentage of Participants With an Injection-site Adverse Event   [ Time Frame: Up to 5 days after each 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: Senior Vice President, Global Clinical Development
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: NCT01536405     History of Changes
Other Study ID Numbers: V221-027, P20930
Study First Received: February 16, 2012
Results First Received: May 30, 2014
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration