Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-25 @ 3:19 AM
Study NCT ID:
NCT01077804
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2010-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}, {'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', '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, it being understood that the results of this study are not to be considered confidential. The sponsor review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The purpose of this study was to monitor changes in vaccine effectiveness over time and no collection of adverse events was required. Therefore, no data on adverse events were collected and the number at risk is zero.', 'eventGroups': [{'id': 'EG000', 'title': 'Varivax Vaccinated Children', 'description': 'Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants With an Occurrence of Herpes Zoster Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7585', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Varivax Vaccinated Children', 'description': 'Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 6 weeks to 168 months (14 years) post vaccination', 'description': 'Herpes zoster cases were physician-diagnosed cases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an Occurrence of Breakthrough Varicella', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7585', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Varivax Vaccinated Children', 'description': 'Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.'}], 'classes': [{'title': 'Any Varicella symptoms', 'categories': [{'measurements': [{'value': '1425', 'groupId': 'OG000'}]}]}, {'title': 'Varicella with >50 lesions', 'categories': [{'measurements': [{'value': '362', 'groupId': 'OG000'}]}]}, {'title': 'Varicella with >300 lesions', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 6 weeks to 168 months (14 years) post vaccination', 'description': 'Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of Breakthrough Varicella', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7585', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Varivax Vaccinated Children', 'description': 'Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.'}], 'classes': [{'title': 'Any varicella', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '16.7'}]}]}, {'title': 'Varicella with > 50 lesions', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '4.9'}]}]}, {'title': 'Varicella with > 300 lesions', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 6 weeks to 168 months (14 years) post vaccination', 'description': 'Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.', 'unitOfMeasure': 'Rate per 1000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Herpes Zoster Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7585', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Varivax Vaccinated Children', 'description': 'Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '0.60'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 6 weeks to 168 months (14 years) post vaccination', 'description': 'Herpes zoster cases were physician-diagnosed.', 'unitOfMeasure': 'Rate per 1000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varivax Vaccinated Children', 'description': 'Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7585'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7386'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}]}], 'dropWithdraws': [{'type': 'Unreachable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'Refused to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7585', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Varivax Vaccinated Children', 'description': 'Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '7585', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3714', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3871', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7585', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7585}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2010-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2010-02-26', 'resultsFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2010-02-26', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-09-29', 'studyFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With an Occurrence of Breakthrough Varicella', 'timeFrame': 'From 6 weeks to 168 months (14 years) post vaccination', 'description': 'Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.'}, {'measure': 'Incidence Rate of Breakthrough Varicella', 'timeFrame': 'From 6 weeks to 168 months (14 years) post vaccination', 'description': 'Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an Occurrence of Herpes Zoster Infection', 'timeFrame': 'From 6 weeks to 168 months (14 years) post vaccination', 'description': 'Herpes zoster cases were physician-diagnosed cases.'}, {'measure': 'Incidence Rate of Herpes Zoster Infection', 'timeFrame': 'From 6 weeks to 168 months (14 years) post vaccination', 'description': 'Herpes zoster cases were physician-diagnosed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Varicella', 'Herpes Zoster']}, 'referencesModule': {'references': [{'pmid': '23545380', 'type': 'RESULT', 'citation': 'Baxter R, Ray P, Tran TN, Black S, Shinefield HR, Coplan PM, Lewis E, Fireman B, Saddier P. Long-term effectiveness of varicella vaccine: a 14-Year, prospective cohort study. Pediatrics. 2013 May;131(5):e1389-96. doi: 10.1542/peds.2012-3303. Epub 2013 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of these continuing post-licensure studies is to evaluate the long-term effectiveness of VARIVAX® \\[Varicella Virus Vaccine Live (Oka/Merck)\\] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster.', 'detailedDescription': 'Parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during a six-month period in 1995 (June-November) at KPMCP Northern California were interviewed by telephone at 6-month intervals to ascertain whether their child had varicella or herpes zoster in the 6 months prior to interview. Follow-up continued for a minimum of 14 years after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '12 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '15 years prospective follow-up of the original study cohort', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject was a member of Kaiser Permanente Northern California, age 12-23 months, received a dose of varicella vaccine between June and November 1995, and parents accepted to participate in 15-year follow-up\n\nExclusion Criteria:\n\n* Subjects diagnosed with varicella before study enrollment\n* Subject's parents unable to complete telephone interviews in English, Spanish, or Cantonese"}, 'identificationModule': {'nctId': 'NCT01077804', 'briefTitle': 'A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents', 'orgStudyIdInfo': {'id': 'V210-036'}, 'secondaryIdInfos': [{'id': '2010_014', 'type': 'OTHER', 'domain': 'Merck'}, {'id': 'EP08005.002', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Varivax vaccinated children', 'description': 'Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roger Baxter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}