ProQuad Dose Selection Study (V221-011)(COMPLETED)

Study Overview
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Brief Summary
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A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

Official Title
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A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections

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: M-M-R II
* Biological: Comparator: PUVV


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 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 (low dose) | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90<br>* Other names: ProQuad;|
| Experimental: 2<br>ProQuad (middle dose) | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90<br>* Other names: ProQuad;|
| Experimental: 3<br>ProQuad (high dose) | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90<br>* Other names: ProQuad;|
| Active Comparator: 4<br>M-M-R II + PUVV | Biological: Comparator: M-M-R II<br>* A single 0.5 mL subcutaneous injection at Day 0<br>Biological: Comparator: PUVV<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 Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units | 6 weeks postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles 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 in participants 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 in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline | 6 weeks Postvaccination | 
| Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Participants 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 Visit 1 or Visit 2 | 
| Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.) | 6 weeks Postvaccination | 
| Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.) | 6 weeks Postvaccination | 
| Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.) | 6 weeks Postvaccination | 
| Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.) | 6 weeks postvaccination |