Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 9:54 PM
Study NCT ID:
NCT01062061
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2010-02-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Re-examination Study For Varivax (V210-059 AM2)
Sponsor:
Organization:
Raw JSON
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Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.', 'otherNumAtRisk': 727, 'otherNumAffected': 105, 'seriousNumAtRisk': 727, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 59, 'numAffected': 51}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 62, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.69', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.\n\nChanges resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More AEs by Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Male Participants', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}, {'id': 'OG001', 'title': 'Female Participants', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.63', 'groupId': 'OG000'}, {'value': '37.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9733', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.\n\nChanges resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More AEs by Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '686', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age <2 Years', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}, {'id': 'OG001', 'title': 'Age ≥2 Years', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.01', 'groupId': 'OG000'}, {'value': '65.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.\n\nChanges resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Adverse Drug Reactions (ADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Unexpected AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.00', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Unexpected AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Unexpected ADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Unexpected ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Serious ADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Serious ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Unexpected SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '754'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '727'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Enrolled more than once', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Investigated before study start', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Outside chief indications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Failed to meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'spread': '0.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<2 years', 'categories': [{'measurements': [{'value': '686', 'groupId': 'BG000'}]}]}, {'title': '≥2 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '347', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '380', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 754}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2010-02-02', 'resultsFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2010-02-02', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-16', 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With One or More Adverse Events (AEs)', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.\n\nChanges resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.'}, {'measure': 'Percentage of Participants With One or More AEs by Gender', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.\n\nChanges resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.'}, {'measure': 'Percentage of Participants With One or More AEs by Age', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.\n\nChanges resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.'}, {'measure': 'Percentage of Participants With One or More Adverse Drug Reactions (ADRs)', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out'}, {'measure': 'Percentage of Participants With One or More Unexpected AEs', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome'}, {'measure': 'Percentage of Participants With One or More Unexpected ADRs', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out'}, {'measure': 'Percentage of Participants With One or More Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.'}, {'measure': 'Percentage of Participants With One or More Serious ADRs', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out'}, {'measure': 'Percentage of Participants With One or More Unexpected SAEs', 'timeFrame': 'Up to 42 days after vaccination', 'description': 'Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Varicella'], 'conditions': ['Varicella']}, 'descriptionModule': {'briefSummary': 'This survey is conducted for preparing application materials for re-examination under the Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of VARIVAX through collecting the safety information according to the Re-examination Regulation for New Drugs.', 'detailedDescription': 'This post-marketing survey was conducted in the usual routine practice and the investigator enrolled participants vaccinated with VARIVAX continuously after study start. The purpose of the study was to assess the occurrence of adverse events and to identify factors that may affect the safety of the vaccine under real-life, post-marketing conditions. No hypothesis testing was conducted in this survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Korean participants being vaccinated with VARIVAX in usual practice', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be vaccinated with VARIVAX as a standard of care\n\nExclusion Criteria:\n\n* Participants who have been previously vaccinated with VARIVAX\n* Contraindication with VARIVAX'}, 'identificationModule': {'nctId': 'NCT01062061', 'briefTitle': 'Re-examination Study For Varivax (V210-059 AM2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Re-examination Study for General Vaccine Use to Assess the Safety Profile of Varivax in Usual Practice', 'orgStudyIdInfo': {'id': 'V210-059'}, 'secondaryIdInfos': [{'id': '2010_004', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'VARIVAX', 'description': 'Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.', 'interventionNames': ['Biological: VARIVAX™']}], 'interventions': [{'name': 'VARIVAX™', 'type': 'BIOLOGICAL', 'description': 'Attenuated live varicella vaccine', 'armGroupLabels': ['VARIVAX']}]}, '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'}}}}