{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T13:38:22Z","timestamp":1772804302742,"version":"3.50.1"},"reference-count":27,"publisher":"BMJ","issue":"7","funder":[{"DOI":"10.13039\/100020955","name":"GlaxoSmithKline Biologicals SA","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100020955","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,6,1]]},"published-print":{"date-parts":[[2018,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      South Australia (SA) has the highest notification rate of invasive meningococcal disease in Australia with the majority of cases due to serogroup B.\n                      <jats:italic>Neisseria meningitidis<\/jats:italic>\n                      is carried in the pharynx, with adolescents having the highest rates of carriage. A vaccine designed to offer protection against serogroup B (4CMenB) is licensed in Australia. The SA MenB vaccine carriage study aims to assess the impact of 4CMenB on carriage of\n                      <jats:italic>N. meningitidis<\/jats:italic>\n                      in adolescents.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      This is a parallel cluster randomised controlled trial enrolling year 10, 11 and 12 school students (approximately 16\u201318 years of age) throughout SA, in metropolitan and rural\/remote areas. Schools are randomised to intervention (4CMenB vaccination at baseline) or control (4CMenB vaccination at study completion) with randomisation stratified by school size and socioeconomic status, as measured by the Index of Community Socio-Educational Advantage (Australian Curriculum). Oropharyngeal swabs will be taken from all students at visit 1, and 12 months later from year 11 and 12 students. Students unvaccinated in 2017 will receive vaccine at the 12-month follow-up. Carriage prevalence of\n                      <jats:italic>N. meningitidis<\/jats:italic>\n                      will be determined by PCR at baseline and 12 months following 4CMenB vaccination and compared with carriage prevalence at 12 months in unvaccinated students. A questionnaire will be completed at baseline and 12 months to assess risk factors associated with carriage. The primary outcome of carriage prevalence of disease causing\n                      <jats:italic>N. meningitidis<\/jats:italic>\n                      at 12 months will be compared between groups using logistic regression, with generalised estimating equations used to account for clustering at the school level. The difference in carriage prevalence between groups will be expressed as an OR with 95% CI.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study was approved by the Women\u2019s and Children\u2019s Health Network Human Research Ethics Committee (WCHN HREC). The protocol, informed consent forms, recruitment materials, social media and all participant materials have been reviewed and approved by the WCHN HREC and updated on ClinicalTrials.gov. Results will be published in international peer-reviewed journals and presented at national and international conferences. The study findings will be provided in public forums and to study participants and participating schools.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ACTRN12617000079347.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03089086\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\">NCT03089086<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-020988","type":"journal-article","created":{"date-parts":[[2018,7,10]],"date-time":"2018-07-10T10:12:34Z","timestamp":1531217554000},"page":"e020988","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":30,"title":["B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of\n                    <i>Neisseria meningitidis<\/i>\n                    in adolescents"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct03089086","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"given":"Helen S","family":"Marshall","sequence":"first","affiliation":[{"name":"Vaccinology and Immunology Research Trials Unit, Women\u2019s and Children\u2019s Hospital Adelaide, Adelaide, South Australia, Australia"},{"name":"Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"McMillan","sequence":"additional","affiliation":[{"name":"Vaccinology and Immunology Research Trials Unit, Women\u2019s and Children\u2019s Hospital Adelaide, Adelaide, South Australia, Australia"},{"name":"Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann","family":"Koehler","sequence":"additional","affiliation":[{"name":"Communicable Disease Control Branch, SA Health, Adelaide, South Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Lawrence","sequence":"additional","affiliation":[{"name":"Microbiology Department, SA Pathology, Adelaide, South Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenny M","family":"MacLennan","sequence":"additional","affiliation":[{"name":"Department of Zoology, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin C J","family":"Maiden","sequence":"additional","affiliation":[{"name":"Department of Zoology, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Ramsay","sequence":"additional","affiliation":[{"name":"Immunisation Department, Public Health England, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shamez N","family":"Ladhani","sequence":"additional","affiliation":[{"name":"Immunisation Department, Public Health England, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Trotter","sequence":"additional","affiliation":[{"name":"Immunisation Department, Public Health England, London, UK"},{"name":"Department of Veterinary Medicine, University of Cambridge, Cambridge, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ray","family":"Borrow","sequence":"additional","affiliation":[{"name":"Meningococcal Reference Unit, Public Health England, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Finn","sequence":"additional","affiliation":[{"name":"School Clinical Sciences, University of Bristol, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Sullivan","sequence":"additional","affiliation":[{"name":"School of Public Health, University of Adelaide, Adelaide, South Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Richmond","sequence":"additional","affiliation":[{"name":"Marshall Center for Infectious Disease Research and Training, School of Biomedical Science, University of Western Australia, Perth, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlene M","family":"Kahler","sequence":"additional","affiliation":[{"name":"Marshall Center for Infectious Disease Research and Training, School of Biomedical Science, University of Western Australia, Perth, Western Australia, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Whelan","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kumaran","family":"Vadivelu","sequence":"additional","affiliation":[{"name":"Vaccine Development, GlaxoSmithKline Vaccines, Siena, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2018,7,10]]},"reference":[{"key":"2025121407190254000_8.7.e020988.1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S28410"},{"key":"2025121407190254000_8.7.e020988.2","doi-asserted-by":"publisher","DOI":"10.1186\/1478-7954-11-17"},{"key":"2025121407190254000_8.7.e020988.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.12.032"},{"key":"2025121407190254000_8.7.e020988.4","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(10)70251-6"},{"key":"2025121407190254000_8.7.e020988.5","doi-asserted-by":"publisher","DOI":"10.3201\/eid1206.051297"},{"key":"2025121407190254000_8.7.e020988.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2009.04.061"},{"key":"2025121407190254000_8.7.e020988.7","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268800067492"},{"key":"2025121407190254000_8.7.e020988.8","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1097\/XEB.0000000000000048","article-title":"Control of invasive meningococcal disease: is it achievable?","volume":"14","author":"Marshall","year":"2016","journal-title":"Int J Evid Based Healthc"},{"key":"2025121407190254000_8.7.e020988.9","doi-asserted-by":"crossref","first-page":"E503","DOI":"10.33321\/cdi.2016.40.57","article-title":"Australian meningococcal surveillance programme annual report, 2015","volume":"40","author":"Lahra","year":"2016","journal-title":"Commun Dis Intell Q Rep"},{"key":"2025121407190254000_8.7.e020988.10","unstructured":"The Department of Health. Invasive Meningococcal disease surviellance report. 2017 (cited 9 Jan 2017)."},{"key":"2025121407190254000_8.7.e020988.11","unstructured":"European Centre for Disease Prevention and Control. Annual Epidemiological Report 2016\u2014Inasive meningococcal disease. 2016. https:\/\/ecdc.europa.eu\/en\/publications-data\/invasive-meningococcal-disease-annual-epidemiological-report-2016-2014-data (cited 12 Jul 2017)."},{"key":"2025121407190254000_8.7.e020988.12","doi-asserted-by":"publisher","DOI":"10.1086\/527401"},{"key":"2025121407190254000_8.7.e020988.13","doi-asserted-by":"publisher","DOI":"10.1586\/erv.09.48"},{"issue":"Suppl 4","key":"2025121407190254000_8.7.e020988.14","doi-asserted-by":"crossref","first-page":"D32","DOI":"10.1016\/j.vaccine.2015.05.101","article-title":"Vaccines for prevention of group B meningococcal disease: not your father\u2019s vaccines","volume":"33","author":"Harrison","year":"2015","journal-title":"Vaccine"},{"key":"2025121407190254000_8.7.e020988.15","unstructured":"Immunise Australia Program: Australian Government. Australian Technical Advisory Group on Immunisation (ATAGI) Statement. Advice for immunisation providers regarding the use of Bexsero\u00ae. 2015. http:\/\/www.immunise.health.gov.au\/internet\/immunise\/publishing.nsf\/Content\/atagi-advice-bexsero (cited 16 Aug 2016)."},{"key":"2025121407190254000_8.7.e020988.16","unstructured":"Australian Government Department of Health. Public summary document: multicomponent meningococcal group B vaccine, 0.5 mL, injection, prefilled syringe, Bexsero\u00ae. 2013. http:\/\/www.pbs.gov.au\/info\/industry\/listing\/elements\/pbac-meetings\/psd\/2013-11\/meningococcal-vaccine (cited 12 Jul 2017)."},{"key":"2025121407190254000_8.7.e020988.17","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0158315","article-title":"Temporal changes in BEXSERO\u00ae antigen sequence type associated with genetic lineages of Neisseria meningitidis over a 15-year period in Western Australia","volume":"11","author":"Mowlaboccus","year":"2016","journal-title":"PLoS One"},{"key":"2025121407190254000_8.7.e020988.18","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)31921-3"},{"key":"2025121407190254000_8.7.e020988.19","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60842-4"},{"key":"2025121407190254000_8.7.e020988.20","unstructured":"ACARA. My School; Guide to understanding ICSEA. Sydney: NSW Australian Curriculum Assessment and reporting Authority (ACARA), 2012."},{"key":"2025121407190254000_8.7.e020988.21","doi-asserted-by":"crossref","first-page":"375","DOI":"10.1080\/21645515.2015.1090069","article-title":"Population density profiles of nasopharyngeal carriage of 5 bacterial species in pre-school children measured using quantitative PCR offer potential insights into the dynamics of transmission","volume":"12","author":"Thors","year":"2016","journal-title":"Hum Vaccin Immunother"},{"key":"2025121407190254000_8.7.e020988.22","unstructured":"The University of Adelaide. B Part of It. 2016. https:\/\/www.bpartofit.com.au\/ (cited 12 Jul 2017)."},{"key":"2025121407190254000_8.7.e020988.23","doi-asserted-by":"crossref","first-page":"1080","DOI":"10.1097\/INF.0000000000001237","article-title":"Density distribution of pharyngeal carriage of meningococcus in healthy young adults: new approaches to studying the epidemiology of colonization and vaccine indirect effects","volume":"35","author":"Finn","year":"2016","journal-title":"Pediatr Infect Dis J"},{"key":"2025121407190254000_8.7.e020988.24","doi-asserted-by":"publisher","DOI":"10.1128\/CVI.00202-12"},{"key":"2025121407190254000_8.7.e020988.25","doi-asserted-by":"publisher","DOI":"10.3201\/eid0606.0006"},{"key":"2025121407190254000_8.7.e020988.26","doi-asserted-by":"crossref","first-page":"332","DOI":"10.5694\/j.1326-5377.1990.tb120972.x","article-title":"Neisseria meningitidis in a school population in Queensland","volume":"152","author":"Ingram","year":"1990","journal-title":"Med J Aust"},{"key":"2025121407190254000_8.7.e020988.27","doi-asserted-by":"publisher","DOI":"10.1370\/afm.141"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2017-020988","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T15:19:11Z","timestamp":1765725551000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2017-020988"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,7]]},"references-count":27,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2018,7,10]]},"published-print":{"date-parts":[[2018,7]]}},"alternative-id":["10.1136\/bmjopen-2017-020988"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2017-020988","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,7]]}}}