Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)

Study Overview
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Brief Summary
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This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.

Official Title
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A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II

Conditions
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Varicella

Intervention / Treatment
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* Biological: VARIVAX™ New Seed Process
* 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 for varicella, herpes zoster, measles, mumps, and rubella 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 receive them during the course of the study History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™ Received salicylates within 14 days prior to study vaccination Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination History of seizure disorder, including febrile seizure Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination History of thrombocytopenia 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VARIVAX™ NSP + M-M-R II™<br>VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 | Biological: VARIVAX™ New Seed Process<br>* Varicella virus vaccine live manufactured with a new seed process<br>Biological: M-M-R II™<br>* Measles, Mumps, and Rubella virus vaccine live<br>|
| Active Comparator: VARIVAX™ 2007 Process + M-M-R II™<br>VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 | Biological: VARIVAX™ 2007 process<br>* Varicella virus vaccine live manufactured with the 2007 process<br>Biological: M-M-R II™<br>* Measles, Mumps, and Rubella virus vaccine live<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL |  | 6 weeks (43 days) after vaccination 1 | 
| Geometric Mean Titer of VZV Antibodies | Antibody titers were measured with gpELISA. | 6 weeks (43 days) after vaccination 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Fever (>=102.2 °F Oral Equivalent) |  | Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days) | 
| Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1 |  | Up to 42 days after Vaccination 1 | 
| Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2 |  | Up to 42 days after Vaccination 2 | 
| Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1 |  | Up to 5 days after Vaccination 1 | 
| Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2 |  | Up to 5 days after Vaccination 2 |