Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05873751
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2023-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.
Sponsor:
Organization:
Raw JSON
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Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data for adverse events and deaths were not assessed/evaluated during the study; hence timeframe is not applicable.', 'description': 'This study involved data that existed as structured data and in these data sources individual identifying information was not available. The minimum criteria for reporting an adverse event (AE) (i.e., identifiable patient, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not planned to be evaluated.', 'eventGroups': [{'id': 'EG000', 'title': 'Exposed Cohort: Vaccinated With Trumenba + MenACWY', 'description': 'Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Exposed Cohort: Vaccinated With MenACWY Only', 'description': 'Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214552', 'groupId': 'OG000'}, {'value': '1092826', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort: Vaccinated With Trumenba + MenACWY', 'description': 'Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study.'}, {'id': 'OG001', 'title': 'Non-Exposed Cohort: Vaccinated With MenACWY Only', 'description': 'Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '2327', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Calibrated VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.74', 'ciLowerLimit': '-10.35', 'ciUpperLimit': '15.59', 'estimateComment': 'VE = 1 - HR\\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)', 'description': 'Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were included in this retrospective study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92661', 'groupId': 'OG000'}, {'value': '1092826', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort: Vaccinated With Trumenba + MenACWY', 'description': 'Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study.'}, {'id': 'OG001', 'title': 'Non-Exposed Cohort: Vaccinated With MenACWY Only', 'description': 'Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '2327', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Calibrated VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-23.50', 'ciUpperLimit': '13.85', 'estimateComment': 'VE = 1 - HR\\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)', 'description': 'Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were included in this retrospective study. "Overall Number of Participants Analyzed" signifies participants who received at least two doses of Trumenba were included in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214552', 'groupId': 'OG000'}, {'value': '1092826', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort: Vaccinated With Trumenba + MenACWY', 'description': 'Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study.'}, {'id': 'OG001', 'title': 'Non-Exposed Cohort: Vaccinated With MenACWY Only', 'description': 'Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1138', 'groupId': 'OG000'}, {'value': '7261', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Calibrated VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.74', 'ciLowerLimit': '-10.35', 'ciUpperLimit': '15.59', 'estimateComment': 'VE = 1 - HR\\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)', 'description': 'Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were included in this retrospective study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92661', 'groupId': 'OG000'}, {'value': '1092826', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed Cohort: Vaccinated With Trumenba + MenACWY', 'description': 'Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study.'}, {'id': 'OG001', 'title': 'Non-Exposed Cohort: Vaccinated With MenACWY Only', 'description': 'Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '584', 'groupId': 'OG000'}, {'value': '7261', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Calibrated VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-23.50', 'ciUpperLimit': '13.85', 'estimateComment': 'VE = 1 - HR\\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)', 'description': 'Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were included in this retrospective study. "Overall Number of Participants Analyzed" signifies participants who received at least two doses of Trumenba were included in this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exposed Cohort: Vaccinated With Trumenba + MenACWY', 'description': 'Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study.'}, {'id': 'FG001', 'title': 'Non-Exposed Cohort: Vaccinated With MenACWY Only', 'description': 'Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214552'}, {'groupId': 'FG001', 'numSubjects': '1092826'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214552'}, {'groupId': 'FG001', 'numSubjects': '1092826'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants (15-30 years of age) who received at least one dose of Trumenba and at least one dose of MenACWY prior to their Trumenba vaccination, between 01 January 2016 and 31 December 2021, were identified and their data (01 January 2016 to 31 December 2022) was retrieved from "IQVIA PharMetrics Plus" database. Available retrospective data was evaluated per objectives of the study during approximately 11 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214552', 'groupId': 'BG000'}, {'value': '1092826', 'groupId': 'BG001'}, {'value': '1307378', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exposed Cohort: Vaccinated With Trumenba + MenACWY', 'description': 'Participants who had received at least one dose of Trumenba and at least one dose of MenACWY vaccine (prior to the Trumenba vaccination) between 01 January 2016 to 31 December 2021, their data was included in this retrospective study. Vaccination was not administered under this study.'}, {'id': 'BG001', 'title': 'Non-Exposed Cohort: Vaccinated With MenACWY Only', 'description': 'Participants who had received at least one dose of MenACWY (but no doses of Trumenba vaccine) between 01-January-2016 to 31-December-2021, their data was included in this retrospective study. It is a reference cohort for this study. Vaccination was not administered under this study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214552', 'groupId': 'BG000'}, {'value': '1092826', 'groupId': 'BG001'}, {'value': '1307378', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.97', 'spread': '1.32', 'groupId': 'BG000'}, {'value': '17.18', 'spread': '1.99', 'groupId': 'BG001'}, {'value': '17.15', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214552', 'groupId': 'BG000'}, {'value': '1092826', 'groupId': 'BG001'}, {'value': '1307378', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '109013', 'groupId': 'BG000'}, {'value': '553213', 'groupId': 'BG001'}, {'value': '662226', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '105539', 'groupId': 'BG000'}, {'value': '539613', 'groupId': 'BG001'}, {'value': '645152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214552', 'groupId': 'BG000'}, {'value': '1092826', 'groupId': 'BG001'}, {'value': '1307378', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Northeast', 'measurements': [{'value': '36193', 'groupId': 'BG000'}, {'value': '199905', 'groupId': 'BG001'}, {'value': '236098', 'groupId': 'BG002'}]}, {'title': 'South', 'measurements': [{'value': '85947', 'groupId': 'BG000'}, {'value': '390076', 'groupId': 'BG001'}, {'value': '476023', 'groupId': 'BG002'}]}, {'title': 'Midwest', 'measurements': [{'value': '68134', 'groupId': 'BG000'}, {'value': '334106', 'groupId': 'BG001'}, {'value': '402240', 'groupId': 'BG002'}]}, {'title': 'West', 'measurements': [{'value': '23963', 'groupId': 'BG000'}, {'value': '161031', 'groupId': 'BG001'}, {'value': '184994', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '7708', 'groupId': 'BG001'}, {'value': '8023', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All eligible participants whose data were included in this retrospective study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-21', 'size': 264484, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-31T10:55', 'hasProtocol': True}, {'date': '2023-04-21', 'size': 475759, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-31T10:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1307378}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2023-05-15', 'resultsFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-31', 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Gonococcal Infection After at Least 1 Dose of Trumenba to Determine Vaccine Effectiveness (VE)', 'timeFrame': 'During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)', 'description': 'Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Gonococcal Infection After at Least 2 Doses of Trumenba to Determine VE', 'timeFrame': 'During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)', 'description': 'Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.'}, {'measure': 'Number of Participants With Chlamydial Infection After at Least 1 Dose of Trumenba to Determine VE', 'timeFrame': 'During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)', 'description': 'Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.'}, {'measure': 'Number of Participants With Chlamydial Infection After at Least 2 Doses of Trumenba to Determine VE', 'timeFrame': 'During follow-up of maximum of 83.5 months (from 14 days after the index date up to 31 December 2022; available retrospective data evaluated for approximately 11 months of this study)', 'description': 'Number of participants (cases) with infection of interest were reported. If a participant had repeated infection only first occurrence was considered, hence one participant with infection was counted only once. VE was calculated as 1 minus the hazard ratio (HR) multiplied by 100. VE is reported as part of statistical data in this outcome measure. The index date (zero time) was the date of the last dose of Trumenba vaccination, after at least one dose of MenACWY for the exposed cohort and first date of MenACWY vaccination for the unexposed cohort.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gonorrhea', 'Chlamydia', 'Meningococcal Vaccines']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1971066', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "Brief Summary:\n\nThe main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection.\n\nThis study looks at data records from a database in the United States.\n\nThis study includes patient's data from the database who:\n\n* Are 15-30 years old.\n* Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine.\n\nThis data has already been collected in the past and is being studied between April and June of 2023.", 'detailedDescription': 'This study is a retrospective cohort study including individuals registered and available in the PharMetrics Plus database from 01 Jan 2016 to 31 Dec 2022 In order to estimate the effect of Trumenba vaccination, the cumulative incidence rate over time of the defined disease of interest among Trumenba + MenACWY vaccines will be compared to that among MenACWY vaccinees. Stratified analysis will be made by age groups, gender and state of residence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female adolescents and young adults 15-30 years old included in the PharMetrics claims database from 01Jan2016 through 31Dec2022 Individuals in this cohort who have received the index vaccination between 2016 and 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals of 15-30 years old registered in the PharMetrics Plus system\n2. Individuals having the index vaccination event at the age of 15-30 in 2016-2021\n\nExclusion Criteria:\n\n1. Individuals having any dose of Bexsero at any time during the study period and prior to the study\n2. Individuals with incomplete information on variables to be collected.'}, 'identificationModule': {'nctId': 'NCT05873751', 'briefTitle': 'A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'B1971066'}, 'secondaryIdInfos': [{'id': 'NCT05873751', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trumenba +MenACWY Vaccinated', 'description': 'Exposure Cohort that received at least one dose of Trumenba and MenACWY vaccine', 'interventionNames': ['Biological: Trumenba Vaccine', 'Biological: MenACWY Vaccine']}, {'label': 'MenACWY Only Vaccinated', 'description': 'Non-exposure (reference cohort) that received at least one dose of MenACWY vaccine and no Trumenba vaccine.', 'interventionNames': ['Biological: MenACWY Vaccine']}], 'interventions': [{'name': 'Trumenba Vaccine', 'type': 'BIOLOGICAL', 'description': 'Trumenba vaccine given as standard of care', 'armGroupLabels': ['Trumenba +MenACWY Vaccinated']}, {'name': 'MenACWY Vaccine', 'type': 'BIOLOGICAL', 'description': 'MenACWY Vaccine given as standard of care', 'armGroupLabels': ['MenACWY Only Vaccinated', 'Trumenba +MenACWY Vaccinated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}