Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

Study Overview
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Brief Summary
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This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.

Detailed Description
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This treatment has been approved for sale to the public.

Official Title
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Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age

Conditions
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Varicella

Intervention / Treatment
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* Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)
* Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
* Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is in good health based on medical history Subject has no history of measles, mumps, rubella, chickenpox, or shingles Exclusion Criteria: Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination Subject has history of immune disorders Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start Subject has received an inactivated vaccine within 14 days of first dose of study vaccine Subject has received a live vaccine within 30 days of first dose of study vaccine Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine Subject has had a fever within 72 hours of study start

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VARIVAX 2007 process + M-M-R II<br> | Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)<br>* VARIVAX (2007 process) in two 0.5 mL doses by injection  6 weeks apart<br>Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)<br>* M-M-R II in two 0.5 mL doses by injection  6 weeks apart<br>|
| Active Comparator: VARIVAX 1999 process + M-M-R II<br> | Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)<br>* VARIVAX (1999 process) in two 0.5 mL doses by injection  6 weeks apart<br>Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)<br>* M-M-R II in two 0.5 mL doses by injection  6 weeks apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). | Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only. | 6 weeks following first vaccination |