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

Completed · Phase 3

Conditions studied: Varicella

In brief

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.

Key facts

Study ID

NCT03239873

Run by

Merck Sharp & Dohme LLC

People needed

600

Starts

2017-10-17

Expected to finish

2019-04-02

Last updated by the study team

2021-01-27

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella

You may not qualify if…

• 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.

Where it is running

• Alabama Clinical Therapeutics ( Site 0018) — Birmingham, Alabama, United States
• Children's Clinic of Jonesboro, PA ( Site 0030) — Jonesboro, Arkansas, United States
• Southland Clinical Research Center ( Site 0017) — Anaheim, California, United States
• Premier Health Research Center, LLC ( Site 0044) — Downey, California, United States
• California Research Foundation ( Site 0003) — San Diego, California, United States
• IMMUNOe Research Centers ( Site 0046) — Thornton, Colorado, United States
• Children's Research at Altamonte Pediatric Associates ( Site 0040) — Lake Mary, Florida, United States
• University of South Florida ( Site 0042) — Tampa, Florida, United States
• Advanced Clinical Research ( Site 0038) — Meridian, Idaho, United States
• Heartland Research Associates, LLC ( Site 0029) — Augusta, Kansas, United States
• Heartland Research Associates, LLC ( Site 0015) — Newton, Kansas, United States
• Cotton O'Neil Research Center ( Site 0014) — Topeka, Kansas, United States
• Kentucky Pediatric/Adult Research Inc ( Site 0012) — Bardstown, Kentucky, United States
• University of Louisville: Pediatric Clinical Trials Unit ( Site 0025) — Louisville, Kentucky, United States
• ACC Pediatric Research ( Site 0041) — Haughton, Louisiana, United States
• The Center For Pharmaceutical Research PC ( Site 0011) — Kansas City, Missouri, United States
• Child Health Care Associates ( Site 0045) — East Syracuse, New York, United States
• Blue Ridge Pediatric & Adolescent Medicine ( Site 0001) — Boone, North Carolina, United States
• Ford, Simpson, Lively & Rice Pediatrics, PLLC ( Site 0037) — Winston-Salem, North Carolina, United States
• Senders Pediatrics ( Site 0034) — Cleveland, Ohio, United States
• Ohio Pediatric Research Association ( Site 0035) — Dayton, Ohio, United States
• Kid's Way Pediatrics ( Site 0047) — Hermitage, Pennsylvania, United States
• Palmetto Pediatrics, PA ( Site 0023) — Charleston, South Carolina, United States
• Coastal Pediatric Research ( Site 0006) — Charleston, South Carolina, United States
• Holston Medical Group Pediatrics ( Site 0024) — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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