Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01078220
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2010-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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. Sponsor review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Details of syncope and cellulitis findings and null findings for hundreds of other general safety analyses will be described in future publications.'}}, 'adverseEventsModule': {'description': 'Per protocol, non-serious adverse events and serious adverse events (SAEs)\n\nwere not required to be captured as part of the study database, therefore, none were collected, and the number at risk is zero.', 'eventGroups': [{'id': 'EG000', 'title': 'Any Dose Safety Population', 'description': 'Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Syncope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189629', 'groupId': 'OG000'}, {'value': '44001', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Dose Safety Population', 'description': 'Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.'}, {'id': 'OG001', 'title': '3-Dose Safety Population', 'description': 'Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '24.21', 'groupId': 'OG000'}, {'value': '13.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.00', 'ciLowerLimit': '3.91', 'ciUpperLimit': '9.21', 'estimateComment': 'Relative risk was approximated by odds ratio, obtained from conditional logistic regression.', 'statisticalMethod': 'unconditional logistic regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.88', 'ciLowerLimit': '1.18', 'ciUpperLimit': '7.08', 'estimateComment': 'Relative risk was approximated by odds ratio, obtained from conditional logistic regression.', 'statisticalMethod': 'unconditional logistic regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'On day of each vaccination', 'description': 'Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study\'s design, diagnosis codes for general safety analyses were not confirmed in this study.', 'unitOfMeasure': 'Rate per 1000 person years', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1740', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnancy Safety Population', 'description': 'Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.'}], 'classes': [{'title': 'Number (No.) of potential congenital anomalies', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}]}]}, {'title': 'No. that underwent medical record review', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}]}]}, {'title': 'No. of confirmed congenital anomalies', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'No. associated with Gardasil by safety committee', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of Gardasil in pregnancy up to 6 months after birth', 'description': 'Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.', 'unitOfMeasure': 'Number of congenital anomalies', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.'}, {'type': 'SECONDARY', 'title': 'Number of Miscarriages Among Females Who Received Gardasil During Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1740', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnancy Safety Population', 'description': 'Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.'}], 'classes': [{'title': 'No. of potential miscarriages indentified', 'categories': [{'measurements': [{'value': '633', 'groupId': 'OG000'}]}]}, {'title': 'No. that underwent medical record review', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No. of confirmed miscarriages', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'No. associated with Gardasil by safety committee', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of Gardasil in pregnancy up to pregnancy resolution', 'description': 'Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.', 'unitOfMeasure': 'Number of miscarriages', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.'}, {'type': 'SECONDARY', 'title': 'Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autoimmune Safety Population', 'description': 'Any female with at least 12 months of membership at a MCO prior to their first dose of Gardasil, in order to exclude pre-existing conditions prior to their first dose of Gardasil.'}], 'classes': [{'title': 'No. of potential autoimmune cases', 'categories': [{'measurements': [{'value': '719', 'groupId': 'OG000'}]}]}, {'title': 'No. that underwent medical record review', 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}]}]}, {'title': 'No. of confirmed new onset cases within 6 months', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'No. associated with Gardasil by safety committee', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 months immediately after each vaccination', 'description': 'Autoimmune cases were defined as newly diagnosed cases within 6 months after any\n\ndose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest.', 'unitOfMeasure': 'Number of autoimmune cases', 'reportingStatus': 'POSTED', 'populationDescription': "Number of females with at least 12 months' membership at a MCO prior to Gardasil."}, {'type': 'PRIMARY', 'title': 'Incidence Rate of Cellulitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189629', 'groupId': 'OG000'}, {'value': '44001', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Dose Safety Population', 'description': 'Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.'}, {'id': 'OG001', 'title': '3-Dose Safety Population', 'description': 'Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months'}], 'classes': [{'title': 'Days 1-14 after vaccination', 'categories': [{'measurements': [{'value': '3.53', 'groupId': 'OG000'}, {'value': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'Days 1-60 after vaccination', 'categories': [{'measurements': [{'value': '2.25', 'groupId': 'OG000'}, {'value': '1.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '1.17', 'ciUpperLimit': '2.3', 'estimateComment': 'Relative risk was approximated by odds ratio, obtained from conditional logistic regression.', 'groupDescription': 'Days 1-14 after vaccination.', 'statisticalMethod': 'unconditional logistic regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.35', 'estimateComment': 'Relative risk was approximated by odds ratio, obtained from conditional logistic regression.', 'groupDescription': 'Days 1-60 after vaccination.', 'statisticalMethod': 'unconditional logistic regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.98', 'estimateComment': 'Relative risk was approximated by odds ratio, obtained from conditional logistic regression.', 'groupDescription': 'Days 1-14 after vaccination.', 'statisticalMethod': 'unconditional logistic regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.21', 'estimateComment': 'Relative risk was approximated by odds ratio, obtained from conditional logistic regression.', 'groupDescription': 'Days 1-60 after vaccination.', 'statisticalMethod': 'unconditional logistic regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days and within 60 days immediately after each vaccination', 'description': 'Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study\'s design, diagnosis codes for general safety analyses were not confirmed in this study.', 'unitOfMeasure': 'Rate per 1000 person years', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Any Dose Safety Population', 'description': 'Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189629'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189629'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '189629', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Any Dose Safety Population', 'description': 'Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<9 years', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Between 9 and 15 years', 'categories': [{'measurements': [{'value': '96839', 'groupId': 'BG000'}]}]}, {'title': 'Between 16 and 26 years', 'categories': [{'measurements': [{'value': '91066', 'groupId': 'BG000'}]}]}, {'title': '>26 years', 'categories': [{'measurements': [{'value': '1679', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '189629', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189629}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2010-02-26', 'resultsFirstSubmitDate': '2011-11-23', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-11-23', 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Syncope', 'timeFrame': 'On day of each vaccination', 'description': 'Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study\'s design, diagnosis codes for general safety analyses were not confirmed in this study.'}, {'measure': 'Incidence Rate of Cellulitis', 'timeFrame': 'Within 14 days and within 60 days immediately after each vaccination', 'description': 'Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study\'s design, diagnosis codes for general safety analyses were not confirmed in this study.'}], 'secondaryOutcomes': [{'measure': 'Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy', 'timeFrame': 'First dose of Gardasil in pregnancy up to 6 months after birth', 'description': 'Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.'}, {'measure': 'Number of Miscarriages Among Females Who Received Gardasil During Pregnancy', 'timeFrame': 'First dose of Gardasil in pregnancy up to pregnancy resolution', 'description': 'Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.'}, {'measure': 'Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil', 'timeFrame': 'within 6 months immediately after each vaccination', 'description': 'Autoimmune cases were defined as newly diagnosed cases within 6 months after any\n\ndose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human Papillomavirus (HPV)'], 'conditions': ['Human Papillomavirus Infection']}, 'referencesModule': {'references': [{'pmid': '21973261', 'type': 'RESULT', 'citation': 'Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, Emery M, Liaw KL, Jacobsen SJ. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012 Feb;271(2):193-203. doi: 10.1111/j.1365-2796.2011.02467.x. Epub 2011 Nov 15.'}, {'pmid': '23027469', 'type': 'RESULT', 'citation': 'Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, Cheetham TC, Liaw KL, Takhar H, Jacobsen SJ. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451.'}], 'seeAlsoLinks': [{'url': 'http://www.encepp.eu/encepp/viewResource.htm?id=17731', 'label': 'EUPAS Register (EUPAS17730)'}]}, 'descriptionModule': {'briefSummary': 'This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Managed Care Organizations (MCO) databases', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n3-Dose Safety Population\n\n* Female 9-26 years at the time of first dose of GARDASIL™\n* Completed the 3-dose regimen of GARDASIL™ per protocol\n\nPregnancy Safety Population\n\n* Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution\n\nAutoimmune Safety Population\n\n* Female who has received at least one dose of GARDASIL™\n* Has been a member of same Managed Care Organization (MCO) for at least 12 months prior to the receipt of GARDASIL™\n\nAny Dose Safety Population\n\n* Female who has received at least one dose of GARDASIL™\n\nExclusion Criteria:\n\n3-Dose Safety Population\n\n* Male\n* Receives incomplete regimen of GARDASIL™\n* Completes the three dose regimen of GARDASIL™ in more than 12 months\n* Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3\n* Younger than 9 or older than 26 years of age at receipt of first dose\n\nPregnancy Safety Population\n\n* Males\n* No record of pregnancy at the Managed Care Organization (MCO)\n\nAutoimmune Safety Population\n\n* Member of the same MCO for less than 12 months prior to receiving the first dose\n* Male'}, 'identificationModule': {'nctId': 'NCT01078220', 'briefTitle': 'Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting', 'orgStudyIdInfo': {'id': 'V501-031'}, 'secondaryIdInfos': [{'id': '2010_019'}, {'id': 'EP08014.031', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '3-Dose Safety Population (Primary)', 'description': 'Females between ages 9 to 26 at receipt of the first dose of GARDASIL who are members of the participating MCOs and have completed the 3-dose regimen of GARDSIL vaccination with 12 months.'}, {'label': 'Pregnancy Safety Population', 'description': 'Females who received at least one dose of GARDASIL during pregnancy.'}, {'label': 'Autoimmune Safety Population', 'description': 'Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL.'}, {'label': 'Any Dose Safety Population (Secondary)', 'description': 'Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}