Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 8:04 AM
Study NCT ID:
NCT00444860
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2007-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ZOSTAVAX(R) Local Registration Trial (V211-019)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Taiwan']}, 'interventionBrowseModule': {'meshes': [{'id': 'D053061', 'term': 'Herpes Zoster Vaccine'}], 'ancestors': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2007-03-07', 'studyFirstSubmitQcDate': '2007-03-07', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.', 'timeFrame': 'prevaccination and 4 weeks postvaccination'}]}, 'conditionsModule': {'conditions': ['Varicella Virus Infection']}, 'referencesModule': {'references': [{'pmid': '25681662', 'type': 'RESULT', 'citation': 'Yao CA, Chen LK, Huang KC. The immunogenicity and safety of zoster vaccine in Taiwanese adults. Vaccine. 2015 Mar 24;33(13):1515-7. doi: 10.1016/j.vaccine.2015.01.085. Epub 2015 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent\n* All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test\n\n * Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea\n* A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination\n\n * Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy\n* Subject Must Sign Informed Consent Prior To Any Study Procedure\n* Subject Must Be afebrile (\\<38.3 °C Oral) On Day Of Vaccination\n* Any Underlying Chronic Illness Must Be In Stable Condition'}, 'identificationModule': {'nctId': 'NCT00444860', 'briefTitle': 'ZOSTAVAX(R) Local Registration Trial (V211-019)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan', 'orgStudyIdInfo': {'id': 'V211-019'}, 'secondaryIdInfos': [{'id': 'MKV211-019'}, {'id': '2007_008'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Zostavax', 'interventionNames': ['Biological: Zoster Vaccine, Live, (Oka-Merck)']}], 'interventions': [{'name': 'Zoster Vaccine, Live, (Oka-Merck)', 'type': 'BIOLOGICAL', 'otherNames': ['Zostavax'], 'description': 'A single dose of 0.65 ml of Zostavax injection was given to each study subject', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}