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

Merck Sharp & Dohme (MSD) logo

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

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

Trial documents
1

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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