Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
NCT ID: NCT03239873
Last Updated: 2021-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2017-10-17
2019-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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
VARIVAX® PE34 Process
Varicella virus vaccine live manufactured with a new passage extension process (PE34)
M-M-R II®
Measles, Mumps, and Rubella virus vaccine live
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
VARIVAX® 2016 Commercial Process
Varicella virus vaccine live manufactured with the 2016 commercial process
M-M-R II®
Measles, Mumps, and Rubella virus vaccine live
Interventions
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VARIVAX® PE34 Process
Varicella virus vaccine live manufactured with a new passage extension process (PE34)
VARIVAX® 2016 Commercial Process
Varicella virus vaccine live manufactured with the 2016 commercial process
M-M-R II®
Measles, Mumps, and Rubella virus vaccine live
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
12 Months
23 Months
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Benchmark Research ( Site 0005)
Austin, Texas, United States
University of Texas Medical Branch at Galveston ( Site 0032)
Galveston, Texas, United States
West Houston Clinical Research Services ( Site 0009)
Houston, Texas, United States
Pediatric Healthcare of Northwest Houston ( Site 0027)
Tomball, Texas, United States
Tanner Clinic ( Site 0010)
Layton, Utah, United States
Wee Care Pediatrics-Roy ( Site 0043)
Roy, Utah, United States
J Lewis Research Inc / Foothill Family Clinic ( Site 0016)
Salt Lake City, Utah, United States
J Lewis Research Inc/Foothill Family Clinic South ( Site 0004)
Salt Lake City, Utah, United States
J Lewis Research Inc/Jordan River Family Medicine ( Site 0019)
South Jordan, Utah, United States
Wee Care Pediatrics ( Site 0036)
Syracuse, Utah, United States
Advanced Clinical Research ( Site 0020)
West Jordan, Utah, United States
Pediatric Research of Charlottesville, LLC ( Site 0039)
Charlottesville, Virginia, United States
Countries
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References
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Silas PE, Zissman EN, Gardner J, Helian S, Lee AW, Platt HL. A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R II). Hum Vaccin Immunother. 2020 Nov 1;16(11):2634-2640. doi: 10.1080/21645515.2020.1743122. Epub 2020 May 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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V210-A03
Identifier Type: OTHER
Identifier Source: secondary_id
2017-001910-27
Identifier Type: OTHER
Identifier Source: secondary_id
V210-A03
Identifier Type: -
Identifier Source: org_study_id
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