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Protocol for a phase IV, Experimental Human Pneumococcal Challenge (EHPC) model to investigate Streptococcus pneumoniae serotype 3 (SPN3) colonisation following PCV15, a double-blind randomised controlled trial in healthy participants aged 18-50 years in the UK (RATIONALE-15).

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Title: Protocol for a phase IV, Experimental Human Pneumococcal Challenge (EHPC) model to investigate Streptococcus pneumoniae serotype 3 (SPN3) colonisation following PCV15, a double-blind randomised controlled trial in healthy participants aged 18-50 years in the UK (RATIONALE-15).
Authors: Macedo BR; Department of Paediatrics, University of Oxford, Oxford, UK., Solórzano C; Department of Paediatrics, University of Oxford, Oxford, UK., Hyder-Wright A; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.; Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK., Lustosa Martinelli J; Department of Paediatrics, University of Oxford, Oxford, UK., Robinson H; Department of Paediatrics, University of Oxford, Oxford, UK., Brito-Mutunayagam S; Department of Paediatrics, University of Oxford, Oxford, UK., Urban BC; Department of Paediatrics, University of Oxford, Oxford, UK., Codreanu T; Department of Paediatrics, University of Oxford, Oxford, UK., Elterish F; Department of Paediatrics, University of Oxford, Oxford, UK., Mitsi E; Department of Paediatrics, University of Oxford, Oxford, UK., Howard A; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK., El Safadi D; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK., Tanha K; Department of Paediatrics, University of Oxford, Oxford, UK., Liu X; Department of Paediatrics, University of Oxford, Oxford, UK., Mazur O; Department of Paediatrics, University of Oxford, Oxford, UK., Ramasamy MN; Department of Paediatrics, University of Oxford, Oxford, UK., Collins A; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.; Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK., Ferreira DM; Department of Paediatrics, University of Oxford, Oxford, UK daniela.ferreira@paediatrics.ox.ac.uk., Drysdale SB; Department of Paediatrics, University of Oxford, Oxford, UK.
Source: BMJ open [BMJ Open] 2025 Nov 24; Vol. 15 (11), pp. e106028. Date of Electronic Publication: 2025 Nov 24.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
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  Data: Protocol for a phase IV, Experimental Human Pneumococcal Challenge (EHPC) model to investigate Streptococcus pneumoniae serotype 3 (SPN3) colonisation following PCV15, a double-blind randomised controlled trial in healthy participants aged 18-50 years in the UK (RATIONALE-15).
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  Data: <searchLink fieldCode="AU" term="%22Macedo+BR%22">Macedo BR</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Solórzano+C%22">Solórzano C</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Hyder-Wright+A%22">Hyder-Wright A</searchLink>; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.; Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.<br /><searchLink fieldCode="AU" term="%22Lustosa+Martinelli+J%22">Lustosa Martinelli J</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Robinson+H%22">Robinson H</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Brito-Mutunayagam+S%22">Brito-Mutunayagam S</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Urban+BC%22">Urban BC</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Codreanu+T%22">Codreanu T</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Elterish+F%22">Elterish F</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Mitsi+E%22">Mitsi E</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Howard+A%22">Howard A</searchLink>; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.<br /><searchLink fieldCode="AU" term="%22El+Safadi+D%22">El Safadi D</searchLink>; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.<br /><searchLink fieldCode="AU" term="%22Tanha+K%22">Tanha K</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Liu+X%22">Liu X</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Mazur+O%22">Mazur O</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Ramasamy+MN%22">Ramasamy MN</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Collins+A%22">Collins A</searchLink>; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.; Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.<br /><searchLink fieldCode="AU" term="%22Ferreira+DM%22">Ferreira DM</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK daniela.ferreira@paediatrics.ox.ac.uk.<br /><searchLink fieldCode="AU" term="%22Drysdale+SB%22">Drysdale SB</searchLink>; Department of Paediatrics, University of Oxford, Oxford, UK.
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  Data: <searchLink fieldCode="JN" term="%22101552874%22">BMJ open</searchLink> [BMJ Open] 2025 Nov 24; Vol. 15 (11), pp. e106028. <i>Date of Electronic Publication: </i>2025 Nov 24.
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