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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-07

Study Completion Date

2015-10-13

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.

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Detailed Description

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Conditions

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Varicella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VARIVAX™ 2007 Process + M-M-R II™

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

Group Type ACTIVE_COMPARATOR

VARIVAX™ 2007 process

Intervention Type BIOLOGICAL

Varicella virus vaccine live manufactured with the 2007 process

M-M-R II™

Intervention Type BIOLOGICAL

Measles, Mumps, and Rubella virus vaccine live

VARIVAX™ NSP + M-M-R II™

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

Group Type EXPERIMENTAL

VARIVAX™ New Seed Process

Intervention Type BIOLOGICAL

Varicella virus vaccine live manufactured with a new seed process

M-M-R II™

Intervention Type BIOLOGICAL

Measles, Mumps, and Rubella virus vaccine live

Interventions

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VARIVAX™ New Seed Process

Varicella virus vaccine live manufactured with a new seed process

Intervention Type BIOLOGICAL

VARIVAX™ 2007 process

Varicella virus vaccine live manufactured with the 2007 process

Intervention Type BIOLOGICAL

M-M-R II™

Measles, Mumps, and Rubella virus vaccine live

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes