Purpose

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial 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® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process, and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.

Condition

Eligibility

Eligible Ages
Between 12 Months and 23 Months
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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® - Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems - 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 - Has a diagnosis of active untreated tuberculosis - Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®
VARIVAX® Passage Extension (PE34) Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
  • Biological: VARIVAX® PE34 Process
    Varicella virus vaccine live manufactured with a new passage extension process (PE34)
  • Biological: M-M-R II®
    Measles, Mumps, and Rubella virus vaccine live
Active Comparator
VARIVAX® 2016 Commercial Process + M-M-R II®
VARIVAX® 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R II® vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91
  • Biological: VARIVAX® 2016 Commercial Process
    Varicella virus vaccine live manufactured with the 2016 commercial process
  • Biological: M-M-R II®
    Measles, Mumps, and Rubella virus vaccine live

More Details

Status
Completed
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.