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dc.contributor.authorMarshall, Helen S
dc.contributor.authorMcMillan, Mark
dc.contributor.authorKoehler, Ann
dc.contributor.authorLawrence, Andrew
dc.contributor.authorMacLennan, Jenny M
dc.contributor.authorMaiden, Martin CJ
dc.contributor.authorRamsay, Mary
dc.contributor.authorLadhani, Shamez N
dc.contributor.authorTrotter, Caroline
dc.contributor.authorBorrow, Ray
dc.contributor.authorFinn, Adam
dc.contributor.authorSullivan, Thomas
dc.contributor.authorRichmond, Peter
dc.contributor.authorKahler, Charlene M
dc.contributor.authorWhelan, Jane
dc.contributor.authorVadivelu, Kumaran
dc.date.accessioned2018-09-05T12:50:31Z
dc.date.available2018-09-05T12:50:31Z
dc.date.issued2018-07-10
dc.identifier.issn2044-6055
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/279623
dc.description.abstractINTRODUCTION: South Australia (SA) has the highest notification rate of invasive meningococcal disease in Australia with the majority of cases due to serogroup B. Neisseria meningitidis 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. meningitidis in adolescents. METHODS AND ANALYSIS: This is a parallel cluster randomised controlled trial enrolling year 10, 11 and 12 school students (approximately 16-18 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. meningitidis 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. meningitidis 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. ETHICS AND DISSEMINATION: The study was approved by the Women's and Children's 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. TRIAL REGISTRATION NUMBER: ACTRN12617000079347. NCT03089086; Pre-results.
dc.format.mediumElectronic
dc.languageeng
dc.publisherBMJ
dc.rightsAttribution-NonCommercial 4.0 International (CC BY-NC 4.0)
dc.subjectPharynx
dc.subjectHumans
dc.subjectNeisseria meningitidis
dc.subjectMeningococcal Vaccines
dc.subjectPrevalence
dc.subjectRisk Factors
dc.subjectCarrier State
dc.subjectResearch Design
dc.subjectSchools
dc.subjectAdolescent
dc.subjectSouth Australia
dc.subjectRandomized Controlled Trials as Topic
dc.titleB Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of Neisseria meningitidis in adolescents.
dc.typeArticle
prism.issueIdentifier7
prism.publicationDate2018
prism.publicationNameBMJ Open
prism.startingPagee020988
prism.volume8
dc.identifier.doi10.17863/CAM.26994
dcterms.dateAccepted2018-06-01
rioxxterms.versionofrecord10.1136/bmjopen-2017-020988
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2018-07-10
dc.contributor.orcidTrotter, Caroline [0000-0003-4000-2708]
dc.identifier.eissn2044-6055
rioxxterms.typeJournal Article/Review
cam.issuedOnline2018-07-10


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