A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

Study Overview
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Brief Summary
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The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.

Official Title
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Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age

Conditions
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Rubella, Measles, Mumps, Varicella

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In good health Received primary dose of M-M-R II at less than or equal to 12 months of age Received primary dose of Varivax at less than or equal to 12 months of age Negative history of varicella, zoster, measles, mumps, and rubella Exclusion Criteria: history of receiving more than once dose of M-M-R II or Varivax 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 Receipt of immune globulin, or blood product in the past 5 months

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

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 + Placebo | Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)<br>* A Single 0.5 mL subcutaneous injection at Day 1<br>* Other names: ProQuad;Biological: Comparator: Placebo<br>* A Single 0.5 mL subcutaneous placebo injection at Day 1<br>|
| Active Comparator: 2<br>M-M-R II + Placebo | Biological: Comparator: M-M-R II<br>* A Single 0.5 mL subcutaneous injection at Day 1<br>Biological: Comparator: Placebo<br>* A Single 0.5 mL subcutaneous placebo injection at Day 1<br>|
| Active Comparator: 3<br>M-M-R II + Varivax | Biological: Comparator: M-M-R II<br>* A Single 0.5 mL subcutaneous injection at Day 1<br>Biological: Comparator: Varivax<br>* A Single 0.5 mL subcutaneous injection at Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Varicella | 6 weeks Postvaccination | 
| Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Measles | 6 weeks Postvaccination | 
| Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Mumps | 6 weeks Postvaccination | 
| Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Rubella | 6 weeks Postvaccination |