Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

Study Overview
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Brief Summary
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This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.

Official Title
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Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) 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: 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 measles, mumps, rubella, varicella, and zoster 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

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 Lot 1 | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* A Single 0.5 mL subcutaneous injection at Day 0<br>* Other names: ProQuad;|
| Experimental: 2<br>ProQuad Lot 2 | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* A Single 0.5 mL subcutaneous injection at Day 0<br>* Other names: ProQuad;|
| Experimental: 3<br>ProQuad Lot 3 | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* A Single 0.5 mL subcutaneous injection at Day 0<br>* Other names: ProQuad;|
| Active Comparator: 4<br>M-M-R II + Varivax | Biological: Comparator: Varivax<br>* A Single 0.5 mL subcutaneous injection at Day 0<br>Biological: Comparator: M-M-R II<br>* A Single 0.5 mL subcutaneous injection 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 | 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 Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL | Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline | 6 weeks Postvaccination | 
| Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL | Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 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 | 
| Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Varicella | 6 weeks Postvaccination | 
| Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Measles. | 6 weeks Postvaccination | 
| Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Mumps. | 6 weeks Postvaccination | 
| Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Rubella | 6 weeks Postvaccination | 
| Number of Participants With Serious Vaccine-related CAEs | Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose). | 6 weeks Postvaccination |