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Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00985153
First received: September 25, 2009
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
Results First Received: January 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Measles
Mumps
Rubella
Varicella
Interventions: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Biological: Comparator: Varivax
Biological: Comparator: M-M-R II

  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

35 clinical sites in the United States and 5 clinical sites in Canada

Date of first participant visit: 12-Apr-2000

Date of last participant visit: 11-May-2001

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
ProQuad™ Lot 1 ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
ProQuad™ Lot 2 ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
ProQuad™ Lot 3 ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
M-M-R™ II + VARIVAX™ VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.

Participant Flow:   Overall Study
    ProQuad™ Lot 1     ProQuad™ Lot 2     ProQuad™ Lot 3     M-M-R™ II + VARIVAX™  
STARTED     985     968     962     1012  
Vaccinated at Visit 1     985     968     962     1012  
COMPLETED     950     924     918     965  
NOT COMPLETED     35     44     44     47  
Lost to Follow-up                 16                 19                 17                 20  
Protocol Violation                 3                 2                 4                 3  
Withdrawal by Subject                 6                 11                 11                 10  
Missed One or More Bleeds                 7                 7                 8                 10  
Incomplete Safety Follow-up                 3                 5                 4                 4  



  Baseline Characteristics
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Reporting Groups
  Description
ProQuad™ Lot 1 ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
ProQuad™ Lot 2 ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
ProQuad™ Lot 3 ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
M-M-R™ II + VARIVAX™ VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
Total Total of all reporting groups

Baseline Measures
    ProQuad™ Lot 1     ProQuad™ Lot 2     ProQuad™ Lot 3     M-M-R™ II + VARIVAX™     Total  
Number of Participants  
[units: participants]
 		  985     968     962     1012     3927  
Age  
[units: Months]
Mean ± Standard Deviation 		  12.7  ± 1.3     12.8  ± 1.4     12.7  ± 1.3     12.8  ± 1.4     12.7  ± 1.4  
Gender  
[units: participants]
 		         
Female     478     448     442     468     1836  
Male     507     520     520     544     2091  
Race/Ethnicity, Customized  
[units: participants]
 		         
African American     120     122     136     150     528  
Asian/Pacific     49     59     40     43     191  
Caucasian     615     630     622     647     2514  
Hispanic     150     113     116     119     498  
Native American     4     0     3     2     9  
Other     47     44     45     51     187  



  Outcome Measures
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1.  Primary:   Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 4

5.  Primary:   Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 5

6.  Primary:   Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 6

7.  Primary:   Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 7

8.  Primary:   Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 8

9.  Primary:   Number of Participants With Serious Vaccine-related CAEs   [ Time Frame: 6 weeks Postvaccination ]
  Show Outcome Measure 9


  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
One additional subject received M-M-R™ II and ProQuad™ vaccines at the same visit in error; this child was excluded from all immunogenicity and safety summaries.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00985153     History of Changes
Other Study ID Numbers: 2009_669, V221-012
Study First Received: September 25, 2009
Results First Received: January 13, 2010
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration