ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

Study Overview
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Brief Summary
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This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

Official 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

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
* Biological: Comparator: Placebo
* Biological: Comparator: Varivax
* Biological: Comparator: M-M-R II


Participation Criteria
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Eligibility 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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ProQuad™ (V221) + Placebo Followed by ProQuad™ | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90<br>* Other names: ProQuad™;Biological: Comparator: Placebo<br>* a single 0.5 mL subcutaneous placebo injection at Day 0<br>|
| Active Comparator: 2<br>M-M-R™ II + VARIVAX™ | Biological: Comparator: Varivax<br>* a single 0.5 mL subcutaneous injection of Varivax at Day 0<br>Biological: Comparator: M-M-R II<br>* a single 0.5 mL subcutaneous injection of M-M-R II at Day 0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline | 6 weeks Postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL | Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline | 6 weeks Postvaccination | 
| 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 | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline | 6 weeks Postvaccination | 
| Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL | Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline | 6 weeks Postvaccination | 
| Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline | 6 weeks Postvaccination |