Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-01 @ 12:47 AM
Study NCT ID:
NCT00130793
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2005-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through 28 days post-vaccination.', 'description': 'The AE presentation includes participants who were vaccinated and had safety follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'ZOSTAVAX™ With PGSU', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\\~45,000 plaque-forming units \\[PFU\\]), 1 subcutaneous 0.65-mL injection', 'otherNumAtRisk': 180, 'otherNumAffected': 63, 'seriousNumAtRisk': 180, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'ZOSTAVAX™ With PGS', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\\~57,000 PFU), 1 subcutaneous 0.65-mL injection', 'otherNumAtRisk': 183, 'otherNumAffected': 84, 'seriousNumAtRisk': 183, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 65}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 70}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 16}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 60}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZOSTAVAX™ With PGSU', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\\~45,000 plaque-forming units \\[PFU\\]), 1 subcutaneous 0.65-mL injection'}, {'id': 'OG001', 'title': 'ZOSTAVAX™ With PGS', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\\~57,000 PFU), 1 subcutaneous 0.65-mL injection'}], 'classes': [{'categories': [{'measurements': [{'value': '717.5', 'groupId': 'OG000', 'lowerLimit': '607.3', 'upperLimit': '847.7'}, {'value': '844.9', 'groupId': 'OG001', 'lowerLimit': '704.4', 'upperLimit': '1013.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks', 'description': 'The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.', 'unitOfMeasure': 'gpELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)'}, {'type': 'SECONDARY', 'title': 'Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZOSTAVAX™ With PGSU', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\\~45,000 plaque-forming units \\[PFU\\]), 1 subcutaneous 0.65-mL injection'}, {'id': 'OG001', 'title': 'ZOSTAVAX™ With PGS', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\\~57,000 PFU), 1 subcutaneous 0.65-mL injection'}], 'classes': [{'title': 'With vaccine related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Without vaccine related SAEs', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All vaccinated subjects with safety follow-up are included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZOSTAVAX™With PGSU', 'description': 'ZOSTAVAX™with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\\~45,000 plaque-forming units \\[PFU\\]), 1 subcutaneous 0.65-mL injection'}, {'id': 'OG001', 'title': 'ZOSTAVAX™ With PGS', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\\~57,000 PFU), 1 subcutaneous 0.65-mL injection'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '3.0'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '3.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From prevaccination (baseline) to 4 weeks postvaccination', 'description': 'GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination', 'unitOfMeasure': 'gpELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ZOSTAVAX™ With PGSU', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\\~45,000 plaque-forming units \\[PFU\\]), 1 subcutaneous 0.65-mL injection'}, {'id': 'FG001', 'title': 'ZOSTAVAX™ With PGS', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\\~57,000 PFU), 1 subcutaneous 0.65-mL injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'Vaccinated', 'achievements': [{'comment': 'One subject was allocated but not vaccinated.', 'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subject received vaccine, completed blood draws, returned vaccination report card (VRC) at Week 4', 'groupId': 'FG000', 'numSubjects': '180'}, {'comment': 'Subject received vaccine, completed blood draws, returned VRC at Week 4', 'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited at 14 sites in the United States.\n\nFirst patient randomized: 08Aug2005; Last patient last visit: 28Nov2005'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ZOSTAVAX™ With PGSU', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\\~45,000 plaque-forming units \\[PFU\\]), 1 subcutaneous 0.65-mL injection'}, {'id': 'BG001', 'title': 'ZOSTAVAX™ With PGS', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\\~57,000 PFU), 1 subcutaneous 0.65-mL injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '9.25', 'groupId': 'BG000'}, {'value': '63.2', 'spread': '8.44', 'groupId': 'BG001'}, {'value': '63.35', 'spread': '8.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Asiatic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic American', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-14', 'studyFirstSubmitDate': '2005-08-11', 'resultsFirstSubmitDate': '2009-05-11', 'studyFirstSubmitQcDate': '2005-08-12', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-11', 'studyFirstPostDateStruct': {'date': '2005-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination', 'timeFrame': 'From prevaccination (baseline) to 4 weeks postvaccination', 'description': 'GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination'}], 'primaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination', 'timeFrame': '4 weeks', 'description': 'The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.'}], 'secondaryOutcomes': [{'measure': 'Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination', 'timeFrame': '4 weeks', 'description': 'Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose'}]}, 'conditionsModule': {'conditions': ['Herpes Zoster']}, 'referencesModule': {'references': [{'pmid': '18077611', 'type': 'BACKGROUND', 'citation': 'Gilderman LI, Lawless JF, Nolen TM, Sterling T, Rutledge RZ, Fernsler DA, Azrolan N, Sutradhar SC, Wang WW, Chan IS, Schlienger K, Schodel F, Silber JL; Zostavax Protocol 010 Study Group. A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax. Clin Vaccine Immunol. 2008 Feb;15(2):314-9. doi: 10.1128/CVI.00310-07. Epub 2007 Dec 12.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.", 'detailedDescription': 'The duration of treatment is 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)\n\nExclusion Criteria:\n\n* Prior history of herpes zoster (shingles)\n* Prior receipt of varicella or zoster vaccine\n* Immunosuppressed'}, 'identificationModule': {'nctId': 'NCT00130793', 'briefTitle': 'A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)', 'orgStudyIdInfo': {'id': 'V211-010'}, 'secondaryIdInfos': [{'id': '2005_035'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zoster vaccine live (Oka/Merck) refrigerated formulation', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\\~45,000 plaque-forming units \\[PFU\\]), 1 subcutaneous 0.65-mL injection', 'interventionNames': ['Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'zoster vaccine live (Oka/Merck) frozen formulation', 'description': 'ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\\~57,000 PFU), 1 subcutaneous 0.65-mL injection', 'interventionNames': ['Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation']}], 'interventions': [{'name': 'Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation', 'type': 'BIOLOGICAL', 'description': '1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1', 'armGroupLabels': ['zoster vaccine live (Oka/Merck) refrigerated formulation']}, {'name': 'Comparator: zoster vaccine live (Oka/Merck) frozen formulation', 'type': 'BIOLOGICAL', 'description': '1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1', 'armGroupLabels': ['zoster vaccine live (Oka/Merck) frozen formulation']}]}, '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'}}}}