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dc.contributor.authorO'Grady, Kerry-Ann F
dc.contributor.authorGrimwood, Keith
dc.contributor.authorCripps, Allan
dc.contributor.authorMulholland, Edward K
dc.contributor.authorMorris, Peter
dc.contributor.authorTorzillo, Paul J
dc.contributor.authorWood, Nicholas
dc.contributor.authorSmith-Vaughan, Heidi
dc.contributor.authorRevell, Amber
dc.contributor.authorWilson, Andrew
dc.contributor.authorVan Asperen, Peter
dc.contributor.authorRichmond, Peter
dc.contributor.authorThornton, Ruth
dc.contributor.authorRablin, Sheree
dc.contributor.authorChang, Anne B
dc.date.accessioned2017-10-03T12:30:36Z
dc.date.available2017-10-03T12:30:36Z
dc.date.issued2013
dc.date.modified2014-10-09T03:40:59Z
dc.identifier.issn1745-6215
dc.identifier.doi10.1186/1745-6215-14-282
dc.identifier.urihttp://hdl.handle.net/10072/58692
dc.description.abstractBackground Recurrent protracted bacterial bronchitis (PBB), chronic suppurative lung disease (CSLD) and bronchiectasis are characterised by a chronic wet cough and are important causes of childhood respiratory morbidity globally. Haemophilus influenzae and Streptococcus pneumoniae are the most commonly associated pathogens. As respiratory exacerbations impair quality of life and may be associated with disease progression, we will determine if the novel 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) reduces exacerbations in these children. Methods A multi-centre, parallel group, double-blind, randomised controlled trial in tertiary paediatric centres from three Australian cities is planned. Two hundred six children aged 18 months to 14 years with recurrent PBB, CSLD or bronchiectasis will be randomised to receive either two doses of PHiD-CV or control meningococcal (ACYW135) conjugate vaccine 2 months apart and followed for 12 months after the second vaccine dose. Randomisation will be stratified by site, age (<6 years and =6 years) and aetiology (recurrent PBB or CSLD/bronchiectasis). Clinical histories, respiratory status (including spirometry in children aged =6 years), nasopharyngeal and saliva swabs, and serum will be collected at baseline and at 2, 3, 8 and 14 months post-enrolment. Local and systemic reactions will be recorded on daily diaries for 7 and 30 days, respectively, following each vaccine dose and serious adverse events monitored throughout the trial. Fortnightly, parental contact will help record respiratory exacerbations. The primary outcome is the incidence of respiratory exacerbations in the 12 months following the second vaccine dose. Secondary outcomes include: nasopharyngeal carriage of H. influenzae and S. pneumoniae vaccine and vaccine- related serotypes; systemic and mucosal immune responses to H. influenzae proteins and S. pneumoniae vaccine and vaccine-related serotypes; impact upon lung function in children aged =6 years; and vaccine safety. Discussion As H. influenzae is the most common bacterial pathogen associated with these chronic respiratory diseases in children, a novel pneumococcal conjugate vaccine that also impacts upon H. influenzae and helps prevent respiratory exacerbations would assist clinical management with potential short- and long-term health benefits. Our study will be the first to assess vaccine efficacy targeting H. influenzae in children with recurrent PBB, CSLD and bronchiectasis.
dc.description.peerreviewedYes
dc.description.publicationstatusYes
dc.format.extent529132 bytes
dc.format.mimetypeapplication/pdf
dc.languageEnglish
dc.language.isoeng
dc.publisherBioMed Central
dc.publisher.placeUnited Kingdom
dc.relation.ispartofstudentpublicationN
dc.relation.ispartofpagefrom1
dc.relation.ispartofpageto11
dc.relation.ispartofjournalTrials
dc.relation.ispartofvolume14
dc.rights.retentionY
dc.subject.fieldofresearchCardiovascular medicine and haematology
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchcode3201
dc.subject.fieldofresearchcode3202
dc.titleDoes a 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine prevent respiratory exacerbations in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: protocol for a randomised controlled trial
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
dcterms.licensehttp://creativecommons.org/licenses/by/2.0
gro.description.notepublicPage numbers are not for citation purposes. Instead, this article has the unique article number of 282.
gro.rights.copyright© 2013 O'Grady et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
gro.date.issued2013
gro.hasfulltextFull Text
gro.griffith.authorCripps, Allan W.
gro.griffith.authorGrimwood, Keith


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