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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00975507 |
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Date of registration:
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10/09/2009 |
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Primary sponsor: |
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Public title:
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ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children
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Scientific title:
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A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children |
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Date of first enrolment:
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March 1998 |
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Target sample size:
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480 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00975507 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- In good health
- Negative clinical history of varicella, shingles, measles, mumps, and rubella
Exclusion Criteria:
- Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or
in combination
- Any immune impairment or deficiency
- Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to
vaccination
- Vaccination with an inactive vaccine with in the past 14 days
- Vaccination with a live vaccine within the past 30 days
- Immune globulin or any blood product administered in the past 3 months
Age minimum:
12 Months
Age maximum:
23 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Measles
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Mumps
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Rubella
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Varicella
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Intervention(s)
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Biological: Comparator: M-M-R II
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Biological: Comparator: Placebo
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Biological: Comparator: Varivax
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Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
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Primary Outcome(s)
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Number of Participants With Postvaccination Varicella Antibody Titer =5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
[Time Frame: 6 weeks Postvaccination]
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Secondary Outcome(s)
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Number of Participants With Postvaccination Measles ELISA Antibody Titer =207.8 mIU/mL
[Time Frame: 6 weeks Postvaccination]
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Number of Participants With Postvaccination Mumps ELISA Antibody Titer =2.0 Ab Units/mL
[Time Frame: 6 weeks Postvaccination]
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Number of Participants With Postvaccination Rubella ELISA Antibody Titer =10 IU/mL
[Time Frame: 6 weeks Postvaccination]
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Number of Participants With Postvaccination Varicella Antibody Titer =5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
[Time Frame: 6 weeks Postvaccination]
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Secondary ID(s)
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2009_660
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V221-009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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