A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)

Study Overview
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Brief Summary
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This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.

Official Title
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A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX Made With the Varicella Enhanced Process (VEP)

Conditions
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Varicella

Intervention / Treatment
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* Biological: VARIVAX™ VEP
* Biological: VARIVAX™ 2007 Process
* Biological: M-M-R™ II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: negative clinical history of measles, mumps, rubella, varicella, and zoster Exclusion Criteria: received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™ received salicylates within 14 days prior to study vaccination exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination fever illness (≥102.2°F [39.0°C]) within 72 hours prior to study vaccination born to a human immunodeficiency virus (HIV)-infected mother participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VARIVAX™ VEP<br> | Biological: VARIVAX™ VEP<br>* Two 0.5 mL subcutaneous doses administered on Days 1 and 91<br>Biological: M-M-R™ II<br>* Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process<br>|
| Active Comparator: VARIVAX™ 2007 Process<br> | Biological: VARIVAX™ 2007 Process<br>* Two 0.5 mL subcutaneous doses administered on Days 1 and 91<br>Biological: M-M-R™ II<br>* Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL |  | Six weeks (43 days) after vaccination 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent) |  | Days 1 to 42 after each vaccination | 
| Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms |  | Days 1 to 42 after each vaccination | 
| Percent of participants with injection-site reactions |  | Days 1 to 5 after each vaccination |