{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T12:24:09Z","timestamp":1789647849189,"version":"4.0.0"},"reference-count":38,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2022,2,16]],"date-time":"2022-02-16T00:00:00Z","timestamp":1644969600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1170965"],"award-info":[{"award-number":["APP1170965"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Invasive meningococcal disease (IMD) causes significant morbidity and mortality worldwide with serogroup B being the predominant serogroup in Australia and other countries for the past few decades. The licensed 4CMenB vaccine is effective in preventing meningococcal B disease. Emerging evidence suggests that although 4CMenB impact on carriage is limited, it may be effective against gonorrhoea due to genetic similarities between Neisseria meningitidis and Neisseria gonorrhoeae. This study protocol describes an observational study that will assess the effect of the 4CMenB vaccine against meningococcal carriage, IMD and gonorrhoea among adolescents in the Northern Territory (NT). All 14\u201319-year-olds residing in the NT with no contraindication for 4CMenB vaccine will be eligible to participate in this cohort study. Following consent, two doses of 4CMenB vaccine will be administered two months apart. An oropharyngeal swab will be collected at baseline and 12 months to detect pharyngeal carriage of Neisseria meningitidis by PCR. The main methodological approaches to assess the effect of 4CMenB involve a nested case control analysis and screening method to assess vaccine effectiveness and an Interrupted Time Series regression analysis to assess vaccine impact. Research ethics approvals have been obtained from Menzies and Central Australian Human Research Ethics Committees and the Western Australian Aboriginal Health Ethics Committee. Results will be provided in culturally appropriate formats for NT remote and regional communities and published in international peer reviewed journals. ClinicalTrials.gov Identifier: NCT04398849.<\/jats:p>","DOI":"10.3390\/vaccines10020309","type":"journal-article","created":{"date-parts":[[2022,2,16]],"date-time":"2022-02-16T20:28:59Z","timestamp":1645043339000},"page":"309","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia\u2014Study Protocol"],"prefix":"10.3390","volume":"10","author":[{"given":"Helen S.","family":"Marshall","sequence":"first","affiliation":[{"name":"Vaccinology and Immunology Research Trials Unit, Women\u2019s and Children\u2019s Health Network, Adelaide, SA 5006, Australia"},{"name":"Adelaide Medical School and Robinson Research Institute, The University of Adelaide, Adelaide, SA 5005, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2434-8370","authenticated-orcid":false,"given":"Prabha H.","family":"Andraweera","sequence":"additional","affiliation":[{"name":"Vaccinology and Immunology Research Trials Unit, Women\u2019s and Children\u2019s Health Network, Adelaide, SA 5006, Australia"},{"name":"Adelaide Medical School and Robinson Research Institute, The University of Adelaide, Adelaide, SA 5005, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Ward","sequence":"additional","affiliation":[{"name":"UQ Poche Centre, The University of Queensland, Saint Lucia, QLD 4072, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Kaldor","sequence":"additional","affiliation":[{"name":"The Kirby Institute, The University of New South Wales, Sydney, NSW 2052, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross","family":"Andrews","sequence":"additional","affiliation":[{"name":"Menzies School of Health Research, Casuarina, NT 0811, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristine","family":"Macartney","sequence":"additional","affiliation":[{"name":"Discipline of Paediatrics and Child Health, The University of Sydney, Sydney, NSW 2006, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Richmond","sequence":"additional","affiliation":[{"name":"Telethon Kids Institute and The University of Western Australia, Crawley, WA 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicki","family":"Krause","sequence":"additional","affiliation":[{"name":"Centre for Disease Control, Department of Health, Northern Territory Government, Darwin, NT 0810, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Koehler","sequence":"additional","affiliation":[{"name":"Communicable Disease Control Branch, SA Health, South Australian Government, Adelaide, SA 5000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Whiley","sequence":"additional","affiliation":[{"name":"UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Saint Lucia, QLD 4072, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne","family":"Giles","sequence":"additional","affiliation":[{"name":"School of Public Health, The University of Adelaide, Adelaide, SA 5005, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosalind","family":"Webby","sequence":"additional","affiliation":[{"name":"Centre for Disease Control, Department of Health, Northern Territory Government, Darwin, NT 0810, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"D\u2019Antoine","sequence":"additional","affiliation":[{"name":"Menzies School of Health Research, Casuarina, NT 0811, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Karnon","sequence":"additional","affiliation":[{"name":"College of Medicine and Public Health, Flinders University, Bedford Park, SA 5001, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rob","family":"Baird","sequence":"additional","affiliation":[{"name":"Northern Territory Pathology, Department of Health, Northern Territory Government, Casuarina, NT 0811, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Lawrence","sequence":"additional","affiliation":[{"name":"SA Pathology, Department of Health, South Australian Government, Adelaide, SA 5000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Petousis-Harris","sequence":"additional","affiliation":[{"name":"Department of General Practice and Primary Health Care, The University of Auckland, Auckland 1023, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"De Wals","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, The Laval University, Quebec, QC G1V 0A6, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belinda","family":"Greenwood-Smith","sequence":"additional","affiliation":[{"name":"Centre for Disease Control, Department of Health, Northern Territory Government, Darwin, NT 0810, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5455-690X","authenticated-orcid":false,"given":"Michael","family":"Binks","sequence":"additional","affiliation":[{"name":"Menzies School of Health Research, Casuarina, NT 0811, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4816-2933","authenticated-orcid":false,"given":"Lisa","family":"Whop","sequence":"additional","affiliation":[{"name":"Menzies School of Health Research, Casuarina, NT 0811, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,2,16]]},"reference":[{"key":"ref_1","first-page":"237","article-title":"Meningococcal disease: Changes in epidemiology and prevention","volume":"4","author":"Chang","year":"2012","journal-title":"Clin. 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