Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT03419533
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2018-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers
Sponsor:
Organization:
Raw JSON
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Meningitidis Genogroups in South Australian School Leavers in 2018/2019', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2709', 'groupId': 'OG000'}, {'value': '4055', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Carriage prevalence of all N. meningitidis genogroups based on gender'}, {'id': 'OG001', 'title': 'Female', 'description': 'Carriage prevalence of all N. meningitidis genogroups based on gender'}], 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in school leavers', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Identify Characteristics Associated With Carriage Prevalence of N. 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Meningitidis Genogroups as Measured by qPCR in School Leavers', 'timeFrame': '2018 to 2019', 'description': 'Density of N. meningitides by qPCR', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers.', 'timeFrame': '2018 to 2019', 'description': 'Whole genome sequencing of N. meningitidis', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2018 School Leavers', 'description': 'South Australian school leavers in 2018 (year 12 in 2017)'}, {'id': 'FG001', 'title': '2019 School Leavers', 'description': 'South Australian school leavers in 2019 (year 12 in 2018)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4107'}, {'groupId': 'FG001', 'numSubjects': '2695'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4107'}, {'groupId': 'FG001', 'numSubjects': '2695'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4107', 'groupId': 'BG000'}, {'value': '2695', 'groupId': 'BG001'}, {'value': '6802', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '2018 School Leavers', 'description': 'South Australian school leavers in 2018 (year 12 in 2017)'}, {'id': 'BG001', 'title': '2019 School Leavers', 'description': 'South Australian school leavers in 2019 (year 12 in 2018)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '18.45', 'spread': '0.71', 'groupId': 'BG000'}, {'value': '18.49', 'spread': '0.51', 'groupId': 'BG001'}, {'value': '18.47', 'spread': '0.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Female', 'categories': [{'title': 'Female', 'measurements': [{'value': '2400', 'groupId': 'BG000'}, {'value': '1660', 'groupId': 'BG001'}, {'value': '4060', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1707', 'groupId': 'BG000'}, {'value': '1035', 'groupId': 'BG001'}, {'value': '2742', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Aboriginal', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Torres Strait Islander', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '3063', 'groupId': 'BG000'}, {'value': '1868', 'groupId': 'BG001'}, {'value': '4931', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '440', 'groupId': 'BG000'}, {'value': '467', 'groupId': 'BG001'}, {'value': '907', 'groupId': 'BG002'}]}]}, {'title': 'Middle Eastern', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-07', 'size': 748986, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-10T20:58', 'hasProtocol': True}, {'date': '2019-08-08', 'size': 1090632, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-10T20:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Oropharyngeal throat swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6802}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-10', 'studyFirstSubmitDate': '2018-01-17', 'resultsFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-10', 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers', 'timeFrame': '2018 to 2019', 'description': 'Density of N. meningitides by qPCR'}, {'measure': 'Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers.', 'timeFrame': '2018 to 2019', 'description': 'Whole genome sequencing of N. meningitidis'}], 'primaryOutcomes': [{'measure': 'Estimate the Difference in Carriage Prevalence of Disease Associated Genogroups of N. Meningitidis (A, B, C, W, X, Y) Between School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018), Following a 4CMenB School Immunisation Program', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in school leavers in 2018 and 2019'}], 'secondaryOutcomes': [{'measure': 'Estimate the Difference in Carriage Prevalence of All N. Meningitidis Genogroups Between South Australian School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018)', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in school leavers in 2018 and 2019'}, {'measure': 'Estimate the Difference in Carriage Prevalence of Each N. Meningitidis Genogroup (A, B, C, W, X, Y) Between South Australian School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018)', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in school leavers in 2018 and 2019'}, {'measure': 'Across Years, Estimate the Difference in Carriage Prevalence of N. Meningitidis Genogroups Causing Disease (A, B, C, W, X, Y) Between South Australian School Leavers Who Received 4CMenB Vaccine and Unvaccinated Students', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in vaccinated and unvaccinated school leavers'}, {'measure': 'Across Years, Estimate the Difference in Carriage Prevalence of All N. Meningitidis Genogroups Between South Australian School Leavers Who Have Received 4CMenB and Unvaccinated Students.', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in vaccinated and unvaccinated school leavers in 2018 and 2019'}, {'measure': 'Across Years, Estimate the Difference in Each N. Meningitidis Genogroup (A, B, C, W, X, Y) Carriage Prevalence Between South Australian School Leavers Who Received 4CMenB Vaccine and Unvaccinated Students', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in vaccinated and unvaccinated school leavers'}, {'measure': 'Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in school leavers'}, {'measure': 'Identify Characteristics Associated With Carriage Prevalence of N. Meningitidis Genogroups Causing Disease (A, B, C, W, X, Y) in South Australian School Leavers in 2018 /2019', 'timeFrame': '2018 to 2019', 'description': 'As measured by PCR in school leavers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neisseria Meningitidis']}, 'referencesModule': {'references': [{'pmid': '31064808', 'type': 'BACKGROUND', 'citation': 'Marshall HS, McMillan M, Koehler A, Lawrence A, MacLennan J, Maiden M, Ramsay M, Ladhani SN, Trotter C, Borrow R, Finn A, Sullivan T, Richmond P, Kahler C, Whelan J, Vadivelu K. B Part of It School Leaver protocol: an observational repeat cross-sectional study to assess the impact of a meningococcal serogroup B (4CMenB) vaccine programme on carriage of Neisseria meningitidis. BMJ Open. 2019 May 6;9(5):e027233. doi: 10.1136/bmjopen-2018-027233.'}, {'pmid': '35895880', 'type': 'DERIVED', 'citation': 'McMillan M, Bednarz J, Leong LEX, Lawrence A, Marshall HS. Impact of COVID-19 Containment Strategies and Meningococcal Conjugate ACWY Vaccination on Meningococcal Carriage in Adolescents. Pediatr Infect Dis J. 2022 Nov 1;41(11):e468-e474. doi: 10.1097/INF.0000000000003660. Epub 2022 Jul 27.'}, {'pmid': '34487174', 'type': 'DERIVED', 'citation': 'McMillan M, Koehler AP, Lawrence A, Sullivan TR, Bednarz J, MacLennan JM, Maiden MCJ, Ladhani SN, Ramsay ME, Trotter C, Borrow R, Finn A, Kahler CM, Whelan J, Vadivelu K, Richmond PC, Marshall HS. B Part of It School Leaver Study: A Repeat Cross-Sectional Study to Assess the Impact of Increasing Coverage With Meningococcal B (4CMenB) Vaccine on Carriage of Neisseria meningitidis. J Infect Dis. 2022 Feb 15;225(4):637-649. doi: 10.1093/infdis/jiab444.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational cross sectional study to evaluate the impact of a 4CMenB vaccination program on oropharyngeal N. meningitidis carriage in vaccinated and unvaccinated school leavers.', 'detailedDescription': 'This carriage study of a cohort of school leavers in South Australia (SA) will provide an opportunity to assess carriage rates in the young adult population (school leavers) following introduction of a 4CMenB vaccination program in senior school students from 2017-2018.This will allow a comparison of carriage prevalence in the two years (2018 and 2019) following implementation of the school program to assess impact on carriage at a population level and compare carriage prevalence in vaccinated versus non-vaccinated groups. Assessment of any association between risk factors and prevalence of nasopharyngeal carriage in school leavers will be made and compared between vaccinated and unvaccinated students.\n\nSchool leavers are defined as students who were enrolled in year 12 at school in the preceding year of recruitment and have been chosen as they are likely to have the highest carriage rates. A high proportion (approximately two thirds) of students will be immunised by the time of throat swab collection in years 2018 and 2019. Assessing carriage in both vaccinated and unvaccinated cohorts will further inform the effect of 4CMenB vaccine on carriage at a population level. This will help determine any herd immunity impact of 4CMenB vaccine and persistence of any effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'School leavers recruited through tertiary education sites and mail out through schools.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* South Australian school leavers between 17 to 25 years of age (enrolled in year 12 in the previous year ie year 2018, students are eligible if they were enrolled in year 12 in 2017, year 2019, students are eligible if they were enrolled in year 12 in 2018).\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT03419533', 'acronym': 'B Part Of It', 'briefTitle': 'Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers', 'organization': {'class': 'OTHER', 'fullName': 'University of Adelaide'}, 'officialTitle': 'An Observational Cross-sectional Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers', 'orgStudyIdInfo': {'id': 'HREC/16/WCHN/140_3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2018 school leavers', 'description': 'South Australian school leavers in 2018 (year 12 in 2017)'}, {'label': '2019 school leavers', 'description': 'South Australian school leavers in 2019 (year 12 in 2018)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5006', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': "Women's and Children's Hosptial", 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Helen Marshall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Adelaide'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Adelaide', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Helen Marshall', 'investigatorAffiliation': 'University of Adelaide'}}}}