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Immunological non-inferiority of a new fully liquid presentation of the MenACWY-CRM vaccine to the licensed vaccine: results from a randomized, controlled, observer-blind study in adolescents and young adults.

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Title: Immunological non-inferiority of a new fully liquid presentation of the MenACWY-CRM vaccine to the licensed vaccine: results from a randomized, controlled, observer-blind study in adolescents and young adults.
Authors: Díez-Domingo J; Vaccine Research Area, FISABIO-Public Health, Valencia, Spain., Tinoco JC; Infectious Disease, Hospital General de Durango, Durango, Mexico., Poder A; Kliiniliste Uuringute Keskus, Tartu, Estonia., Dinleyici EC; Pediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey., Nell H; Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa., Salamanca de la Cueva I; Instituto Hispalense de Pediatria, Seville, Spain., Ince T; Faculty of Medicine, Dokuz Eylul University, Izmir, Turkey., Moreira ED Jr; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil., Ahmed K; Setshaba Research Centre, Tshwane, and Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa., Luz K; Centro de Pesquisas Clinicas de Natal, Rio Grande do Norta, Brazil., Kovshirina Y; Infectious Diseases and Epidemiology, Siberian State Medical University, Tomsk, Russian Federation., Medina Pech CE; Medical Care and Research SA de CV, Mérida, Mexico., Akhund T; Clinical Research and Development Centre, GSK, Siena, Italy., Romolini V; Biostatistics, GSK, Siena, Italy., Costantini M; Biostatistics, GSK, Siena, Italy., Mzolo T; Biostatistics, GSK, Amsterdam, The Netherlands., Kunnel B; Data Strategy & Management, Global Clinical Operations Development - R&D, GSK, Amsterdam, The Netherlands., Lechevin I; Clinical Laboratory Sciences, GSK, Rixensart, Belgium., Aggravi M; Technical Development, GSK, Siena, Italy., Tiberi P; Safety Evaluation and Risk Management, GSK, Siena, Italy., Narendran K; Global Clinical Operations, GSK, Bangalore, India., García-Martínez JA; Medical Department, GSK, Madrid, Spain., Basile V; Global Clinical Delivery, Global Clinical Operations Development, GSK, Siena, Italy., Fragapane E; Clinical Research and Development Centre, GSK, Siena, Italy., Lattanzi M; Clinical Research and Development Centre, GSK, Siena, Italy., Pellegrini M; Clinical Research and Development Centre, GSK, Siena, Italy.
Source: Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2022 Dec 31; Vol. 18 (1), pp. 1981085. Date of Electronic Publication: 2021 Oct 06.
Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Equivalence Trial
Journal Info: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101572652 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2164-554X (Electronic) Linking ISSN: 21645515 NLM ISO Abbreviation: Hum Vaccin Immunother Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Immunological non-inferiority of a new fully liquid presentation of the MenACWY-CRM vaccine to the licensed vaccine: results from a randomized, controlled, observer-blind study in adolescents and young adults.
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  Data: <searchLink fieldCode="AU" term="%22Díez-Domingo+J%22">Díez-Domingo J</searchLink>; Vaccine Research Area, FISABIO-Public Health, Valencia, Spain.<br /><searchLink fieldCode="AU" term="%22Tinoco+JC%22">Tinoco JC</searchLink>; Infectious Disease, Hospital General de Durango, Durango, Mexico.<br /><searchLink fieldCode="AU" term="%22Poder+A%22">Poder A</searchLink>; Kliiniliste Uuringute Keskus, Tartu, Estonia.<br /><searchLink fieldCode="AU" term="%22Dinleyici+EC%22">Dinleyici EC</searchLink>; Pediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey.<br /><searchLink fieldCode="AU" term="%22Nell+H%22">Nell H</searchLink>; Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa.<br /><searchLink fieldCode="AU" term="%22Salamanca+de+la+Cueva+I%22">Salamanca de la Cueva I</searchLink>; Instituto Hispalense de Pediatria, Seville, Spain.<br /><searchLink fieldCode="AU" term="%22Ince+T%22">Ince T</searchLink>; Faculty of Medicine, Dokuz Eylul University, Izmir, Turkey.<br /><searchLink fieldCode="AU" term="%22Moreira+ED+Jr%22">Moreira ED Jr</searchLink>; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil.<br /><searchLink fieldCode="AU" term="%22Ahmed+K%22">Ahmed K</searchLink>; Setshaba Research Centre, Tshwane, and Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa.<br /><searchLink fieldCode="AU" term="%22Luz+K%22">Luz K</searchLink>; Centro de Pesquisas Clinicas de Natal, Rio Grande do Norta, Brazil.<br /><searchLink fieldCode="AU" term="%22Kovshirina+Y%22">Kovshirina Y</searchLink>; Infectious Diseases and Epidemiology, Siberian State Medical University, Tomsk, Russian Federation.<br /><searchLink fieldCode="AU" term="%22Medina+Pech+CE%22">Medina Pech CE</searchLink>; Medical Care and Research SA de CV, Mérida, Mexico.<br /><searchLink fieldCode="AU" term="%22Akhund+T%22">Akhund T</searchLink>; Clinical Research and Development Centre, GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Romolini+V%22">Romolini V</searchLink>; Biostatistics, GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Costantini+M%22">Costantini M</searchLink>; Biostatistics, GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Mzolo+T%22">Mzolo T</searchLink>; Biostatistics, GSK, Amsterdam, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Kunnel+B%22">Kunnel B</searchLink>; Data Strategy & Management, Global Clinical Operations Development - R&D, GSK, Amsterdam, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Lechevin+I%22">Lechevin I</searchLink>; Clinical Laboratory Sciences, GSK, Rixensart, Belgium.<br /><searchLink fieldCode="AU" term="%22Aggravi+M%22">Aggravi M</searchLink>; Technical Development, GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Tiberi+P%22">Tiberi P</searchLink>; Safety Evaluation and Risk Management, GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Narendran+K%22">Narendran K</searchLink>; Global Clinical Operations, GSK, Bangalore, India.<br /><searchLink fieldCode="AU" term="%22García-Martínez+JA%22">García-Martínez JA</searchLink>; Medical Department, GSK, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Basile+V%22">Basile V</searchLink>; Global Clinical Delivery, Global Clinical Operations Development, GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Fragapane+E%22">Fragapane E</searchLink>; Clinical Research and Development Centre, GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Lattanzi+M%22">Lattanzi M</searchLink>; Clinical Research and Development Centre, GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Pellegrini+M%22">Pellegrini M</searchLink>; Clinical Research and Development Centre, GSK, Siena, Italy.
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  Data: <searchLink fieldCode="JN" term="%22101572652%22">Human vaccines & immunotherapeutics</searchLink> [Hum Vaccin Immunother] 2022 Dec 31; Vol. 18 (1), pp. 1981085. <i>Date of Electronic Publication: </i>2021 Oct 06.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Taylor+%26+Francis%22">Taylor & Francis </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101572652 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2164-554X (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2221645515%22">21645515 </searchLink><i>NLM ISO Abbreviation: </i>Hum Vaccin Immunother <i>Subsets: </i>MEDLINE
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