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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Varicella

Treatments: Biological: M-M-R II®; Biological: VARIVAX® PE34 Process; Biological: VARIVAX® 2016 Commercial Process

Study type: Interventional

Funder types: Industry

Identifiers

NCT03239873

2017-001910-27 (Other Identifier)

V210-A03 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

VARIVAX® PE34 Process + Measles, Mumps, Rubella (M-M-R) II®

Experimental group

Description:

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

Treatment:

Biological: M-M-R II®

Biological: VARIVAX® PE34 Process

VARIVAX® 2016 Commercial Process + M-M-R II®

Active Comparator group

Description:

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

Treatment:

Biological: M-M-R II®

Biological: VARIVAX® 2016 Commercial Process