Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-11 @ 10:31 PM
Study NCT ID:
NCT01556451
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2012-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, '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'}]}, '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'}]}}, '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': 'The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 42 days postvaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Zoster Vaccine Live', 'description': 'Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1', 'otherNumAtRisk': 180, 'otherNumAffected': 96, 'seriousNumAtRisk': 180, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection-Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 81, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection-Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 51, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection-Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 68, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Anal Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastric Polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoster Vaccine Live', 'description': 'Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '3.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 4 postvaccination', 'description': 'Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of VZV Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoster Vaccine Live', 'description': 'Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1'}], 'classes': [{'title': 'Day 1 (Baseline)', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000', 'lowerLimit': '59.2', 'upperLimit': '75.5'}]}]}, {'title': 'Week 4 postvaccination', 'categories': [{'measurements': [{'value': '185.4', 'groupId': 'OG000', 'lowerLimit': '167.0', 'upperLimit': '205.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Baseline) and 4 weeks postvaccination', 'description': 'Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV', 'unitOfMeasure': 'gpELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Adverse Experiences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoster Vaccine Live', 'description': 'Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1'}], 'classes': [{'title': 'Injection site adverse experiences', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}]}]}, {'title': 'Non-injection site adverse experiences', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days postvaccination', 'description': 'An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population which included all vaccinated participants who had any safety follow-up'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Discontinued Due to Clinical Adverse Experiences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoster Vaccine Live', 'description': 'Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days postvaccination', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population which included all vaccinated participants who had any safety follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zoster Vaccine Live', 'description': 'Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Zoster Vaccine Live', 'description': 'Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 50 and 59 years', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}, {'title': '60 years or older', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2012-02-17', 'resultsFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2012-03-14', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-19', 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody', 'timeFrame': 'Day 1 (Baseline) and Week 4 postvaccination', 'description': 'Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).'}, {'measure': 'Geometric Mean Titer (GMT) of VZV Antibody', 'timeFrame': 'Day 1 (Baseline) and 4 weeks postvaccination', 'description': 'Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV'}, {'measure': 'Percentage of Participants With Clinical Adverse Experiences', 'timeFrame': 'Up to 42 days postvaccination', 'description': 'An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.'}, {'measure': 'Percentage of Participants Discontinued Due to Clinical Adverse Experiences', 'timeFrame': 'Up to 42 days postvaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Herpes Zoster', 'Shingles']}, 'referencesModule': {'references': [{'pmid': '26770032', 'type': 'RESULT', 'citation': 'Choi WS, Choi JH, Choi JY, Eom JS, Kim SI, Pai H, Peck KR, Sohn JW, Cheong HJ. Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX) in Korean Adults. J Korean Med Sci. 2016 Jan;31(1):13-7. doi: 10.3346/jkms.2016.31.1.13. Epub 2015 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No fever on day of vaccination\n* Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal\n* Underlying chronic illness must be stable\n\nExclusion Criteria:\n\n* History of hypersensitivity reaction to any vaccine component\n* Prior history of herpes zoster\n* Prior receipt of varicella or zoster vaccine\n* Pregnant or breastfeeding\n* Have recently received immunoglobulins or blood products other than autologous blood transfusion\n* Received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study\n* Received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study\n* Use of immunosuppressive therapy\n* Known or suspected immune dysfunction\n* Use of nontopical antiviral therapy with activity against herpes virus\n* Known or suspected active untreated tuberculosis'}, 'identificationModule': {'nctId': 'NCT01556451', 'briefTitle': 'ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-label, Single-arm, Multi-center, Phase IV Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in Korea', 'orgStudyIdInfo': {'id': 'V211-034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zoster Vaccine Live', 'description': 'Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1', 'interventionNames': ['Biological: Zoster Vaccine Live']}], 'interventions': [{'name': 'Zoster Vaccine Live', 'type': 'BIOLOGICAL', 'otherNames': ['ZOSTAVAX™', 'V211'], 'description': 'Zoster vaccine live', 'armGroupLabels': ['Zoster Vaccine Live']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}