A Study of ProQuad™ in Healthy Children in Korea (V221-023)

Study Overview
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Brief Summary
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This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

Official Title
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A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children

Conditions
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Measles, Mumps, Rubella, Varicella

Intervention / Treatment
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* Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
* Biological: M-M-R™ II and Varivax™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is in good health Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster Exclusion Criteria: Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity Subject has a history of seizure disorder Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks Subject has received an inactivated vaccine within the past 14 days Subject has received a live vaccine within the past 30 days Subject has received immune globulin within the past 5 months Subject has a recent history of fever (within the last 72 hours)

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProQuad™<br> | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)<br>* Single administration of 0.5 mL subcutaneous injection<br>* Other names: V221;|
| Active Comparator: M-M-R™ II and Varivax™<br> | Biological: M-M-R™ II and Varivax™<br>* Single administration of 0.5 mL subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL | Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline | 6 weeks postvaccination | 
| Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL | Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline | 6 weeks postvaccination | 
| Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL | Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline | 6 weeks postvaccination | 
| Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL | Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline | 6 weeks postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer of Measles Antibodies | Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline | 6 weeks postvaccination | 
| Geometric Mean Titer of Mumps Antibodies | Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline | 6 weeks postvaccination | 
| Geometric Mean Titer of Rubella Antibodies | Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline | 6 weeks postvaccination | 
| Geometric Mean Titer of VZV (gpELISA) Antibodies | Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline | 6 weeks postvaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Measles, Mumps, Rubella, Varicella