Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 2:23 PM
Study NCT ID:
NCT01626794
Status:
WITHDRAWN
Last Update Posted:
2015-01-27
First Post:
2012-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-26', 'studyFirstSubmitDate': '2012-06-08', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL', 'timeFrame': 'Six weeks (43 days) after vaccination 1'}], 'secondaryOutcomes': [{'measure': 'Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)', 'timeFrame': 'Days 1 to 42 after each vaccination'}, {'measure': 'Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms', 'timeFrame': 'Days 1 to 42 after each vaccination'}, {'measure': 'Percent of participants with injection-site reactions', 'timeFrame': 'Days 1 to 5 after each vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Varicella']}, 'descriptionModule': {'briefSummary': 'This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* negative clinical history of measles, mumps, rubella, varicella, and zoster\n\nExclusion Criteria:\n\n* 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\n* any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity\n* received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study\n* history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™\n* received salicylates within 14 days prior to study vaccination\n* exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination\n* received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination\n* received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination\n* received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination\n* fever illness (≥102.2°F \\[39.0°C\\]) within 72 hours prior to study vaccination\n* born to a human immunodeficiency virus (HIV)-infected mother\n* participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment'}, 'identificationModule': {'nctId': 'NCT01626794', 'briefTitle': 'A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX Made With the Varicella Enhanced Process (VEP)', 'orgStudyIdInfo': {'id': 'V210-062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VARIVAX™ VEP', 'interventionNames': ['Biological: VARIVAX™ VEP', 'Biological: M-M-R™ II']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VARIVAX™ 2007 Process', 'interventionNames': ['Biological: VARIVAX™ 2007 Process', 'Biological: M-M-R™ II']}], 'interventions': [{'name': 'VARIVAX™ VEP', 'type': 'BIOLOGICAL', 'description': 'Two 0.5 mL subcutaneous doses administered on Days 1 and 91', 'armGroupLabels': ['VARIVAX™ VEP']}, {'name': 'VARIVAX™ 2007 Process', 'type': 'BIOLOGICAL', 'description': 'Two 0.5 mL subcutaneous doses administered on Days 1 and 91', 'armGroupLabels': ['VARIVAX™ 2007 Process']}, {'name': 'M-M-R™ II', 'type': 'BIOLOGICAL', 'description': 'Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process', 'armGroupLabels': ['VARIVAX™ 2007 Process', 'VARIVAX™ VEP']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}