Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)

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

  • Varicella

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