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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EAcute otitis media (AOM) is a common medical condition with high incidence in children \u0026lt;5 years of age [Monasta L et al. \u003Cem\u003EPLoS One\u003C\/em\u003E 2012]. Accurate diagnosis is difficult and may partially explain differences in incidence rates in different studies and countries [Toll EC, Nunez DA. \u003Cem\u003EJ Laryngol Otol\u003C\/em\u003E 2012]. A trial with the 11-valent predecessor protein D conjugate vaccine demonstrated efficacy against AOM episodes caused by \u003Cem\u003ES. pneumoniae\u003C\/em\u003E and NTHi [Prymula R et al. \u003Cem\u003ELancet\u003C\/em\u003E 2006]. This article presents preliminary data showing a trend toward positive vaccine effectiveness against AOM episodes for 10-valent pneumococcal nontypeable \u003Cem\u003EH. influenzae\u003C\/em\u003E protein D conjugate vaccine in infants.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EViral Infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EVaccinations\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOtitis Media\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EAcute otitis media (AOM) is a common medical condition with high incidence in children \u0026lt;5 years of age. [Monasta L et al. \u003Cem\u003EPLoS One\u003C\/em\u003E 2012]. The incidence in Europe is \u223c299 cases\/1000 person-years in children under the age of 2 years [Liese J et al. ESPID 2011 Abstract 366]. Accurate diagnosis is difficult and may partially explain differences in incidence rates in different studies and countries [Toll EC, Nunez DA. \u003Cem\u003EJ Laryngol Otol\u003C\/em\u003E 2012]. \u003Cem\u003EStreptococcus pneumoniae\u003C\/em\u003E, nontypeable \u003Cem\u003EHaemophilus influenzae\u003C\/em\u003E (NTHi), and to a lesser extent \u003Cem\u003EMoraxella catarrhalis\u003C\/em\u003E and \u003Cem\u003EStreptococcus pyogenes\u003C\/em\u003E are the bacterial pathogens mainly responsible for AOM [Leibovitz E et al. \u003Cem\u003EPediatr Infect Dis J\u003C\/em\u003E 2004]. A trial with the 11-valent predecessor protein D conjugate vaccine demonstrated efficacy against AOM episodes caused by \u003Cem\u003ES. pneumoniae\u003C\/em\u003E and NTHi [Prymula R et al. \u003Cem\u003ELancet\u003C\/em\u003E 2006].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ETimo Vesikari, MD, University of Tampere, Tampere, Finland, presented preliminary data showing a trend toward positive vaccine effectiveness against AOM episodes for 10-valent pneumococcal nontypeable \u003Cem\u003EH. influenzae\u003C\/em\u003E protein D conjugate vaccine (PHiD-CV) in infants.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThis was a Phase 3\/4, cluster-randomized, double-blind controlled study in Finland [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00839254\u0026amp;atom=%2Fspmdc%2F12%2F14%2F16.atom\u0022\u003ENCT00839254\u003C\/a\u003E] nested within a large invasive pneumococcal disease effectiveness study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00861380\u0026amp;atom=%2Fspmdc%2F12%2F14%2F16.atom\u0022\u003ENCT00861380\u003C\/a\u003E; Palmu A. ESPID 2012 Abstract 1340]. Infants \u0026lt;7 months of age were randomized to receive 1 of 2 dose schedules of PHiD-CV (1 dose at age 3, 4, and 6 months \u003Cem\u003Eor\u003C\/em\u003E 1 dose at age 3 months and a second dose at 5 months; both groups received a booster dose at \u223c12 months) or a control vaccine (hepatitis B) using the same schedules. The study participants were followed for 18 months. AOM surveillance was based on parental reporting of physician diagnosed AOM using an AOM questionnaire. AOM was diagnosed according to the 2004 Finnish national consensus guidelines (abnormal tympanic membrane+presence of middle ear fluid+sign(s) of acute infection). Vaccine effectiveness was calculated as 1 minus rate ratio with 95% CI for subjects reporting \u22651 AOM.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe total vaccinated cohort for effectiveness comprised 4117 infants allocated into 50 clusters with 4019 infants included in the per protocol cohort. Participants were mean age 2.3 months at first dose, about 50% female, and almost exclusively of white European heritage.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAt least 1 AOM was reported in 63% of subjects in the PHiD-CV group and 67% in the control group. Both dose schedules reduced the number of reported cases of AOM; however the results were not statistically significant (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). The results showed a trend toward positive vaccine effectiveness as shown by a reduction in number of subjects reporting \u22651 AOM following PHiD-CV administration. The trend for effectiveness against AOM was stronger using a 3 plus 1 vaccination schedule compared with a 2 plus 1 vaccination schedule. Vaccine effectiveness was similar for OM cases treated with antibiotics (97% of cases).\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/12894\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/12894\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12894\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EResults: Vaccine Effectiveness in Reducing the Number of Subjects Reporting \u22651 AOM.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/12\/14\/16.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn9f1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzn9f1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}