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DC Field | Value | Language |
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dc.contributor.author | Guerra Mendoza, Yolanda | - |
dc.contributor.author | Garric, Elodie | - |
dc.contributor.author | Leach, Amanda | - |
dc.contributor.author | Lievens, Marc | - |
dc.contributor.author | Ofori-Anyinam, Opokua | - |
dc.contributor.author | Pirçon, Jean-Yves | - |
dc.contributor.author | Stegmann, Jens-Ulrich | - |
dc.contributor.author | Vandoolaeghe, Pascale | - |
dc.contributor.author | Otieno, Lucas | - |
dc.contributor.author | Otieno, Walter | - |
dc.contributor.author | Owusu-Agyei, Seth | - |
dc.contributor.author | Sacarlal, Jahit | - |
dc.contributor.author | Masoud, Nahya Salim | - |
dc.contributor.author | Sorgho, Hermann | - |
dc.contributor.author | Tanner, Marcel | - |
dc.contributor.author | Tinto, Halidou | - |
dc.contributor.author | Valea, Innocent | - |
dc.contributor.author | Mtoro, Ali Takadir | - |
dc.contributor.author | Njuguna, Patricia | - |
dc.contributor.author | Oneko, Martina | - |
dc.contributor.author | Otieno, Godfrey Allan | - |
dc.contributor.author | Otieno, Kephas | - |
dc.contributor.author | Gesase, Samwel | - |
dc.contributor.author | Hamel, Mary J. | - |
dc.contributor.author | Hoffman, Irving | - |
dc.contributor.author | Kaali, Seyram | - |
dc.contributor.author | Kamthunzi, Portia | - |
dc.contributor.author | Kremsner, Peter G. | - |
dc.contributor.author | Lanaspa, Miguel | - |
dc.contributor.author | Lell, Bertrand | - |
dc.contributor.author | Lusingu, John | - |
dc.contributor.author | Malabeja, Anangisye | - |
dc.contributor.author | Aide, Pedro Carlos Paulino | - |
dc.contributor.author | Akoo, Pauline | - |
dc.contributor.author | Ansong, Daniel | - |
dc.contributor.author | Asante, Kwaku Poku | - |
dc.contributor.author | Berkley, James A. | - |
dc.contributor.author | Adjei, Samuel | - |
dc.contributor.author | Agbenyega, Tsiri | - |
dc.contributor.author | Agnandji, Selidji Todagbe | - |
dc.contributor.author | Schuerman, Lode | - |
dc.date.accessioned | 2019-06-18T15:08:11Z | - |
dc.date.available | 2019-06-18T15:08:11Z | - |
dc.date.issued | 2019-04-23 | - |
dc.identifier.issn | 2164-5515 | - |
dc.identifier.uri | http://hdl.handle.net/2445/135358 | - |
dc.description.abstract | A phase III, double-blind, randomized, controlled trial (NCT00866619) in sub-Saharan Africa showed RTS,S/AS01 vaccine efficacy against malaria. We now present in-depth safety results from this study. 8922 children (enrolled at 5-17\xC2\xA0months) and 6537 infants (enrolled at 6-12\xC2\xA0weeks) were 1:1:1-randomized to receive 4 doses of RTS,S/AS01 (R3R) or non-malaria control vaccine (C3C), or 3 RTS,S/AS01 doses plus control (R3C). Aggregate safety data were reviewed by a multi-functional team. Severe malaria with Blantyre Coma Score \xE2\x89\xA42 (cerebral malaria [CM]) and gender-specific mortality were assessed post-hoc. Serious adverse event (SAE) and fatal SAE incidences throughout the study were 24.2%-28.4% and 1.5%-2.5%, respectively across groups; 0.0%-0.3% of participants reported vaccination-related SAEs. The incidence of febrile convulsions in children was higher during the first 2-3 days post-vaccination with RTS,S/AS01 than with control vaccine, consistent with the time window of post-vaccination febrile reactions in this study (mostly the day after vaccination). A statistically significant numerical imbalance was observed for meningitis cases in children (R3R: 11, R3C: 10, C3C: 1) but not in infants. CM cases were more frequent in RTS,S/AS01-vaccinated children (R3R: 19, R3C: 24, C3C: 10) but not in infants. All-cause mortality was higher in RTS,S/AS01-vaccinated versus control girls (2.4% vs 1.3%, all ages) in our setting with low overall mortality. The observed meningitis and CM signals are considered likely chance findings, that - given their severity - warrant further evaluation in phase IV studies and WHO-led pilot implementation programs to establish the RTS,S/AS01 benefit-risk profile in real-life settings. | - |
dc.format.extent | 15 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Taylor & Francis | - |
dc.relation.isformatof | Reproducció del document publicat a: http://dx.doi.org/10.1080/21645515.2019.1586040 | - |
dc.relation.ispartof | Human Vaccines & Immunotherapeutics, 2019 | - |
dc.relation.uri | http://dx.doi.org/10.1080/21645515.2019.1586040 | - |
dc.rights | cc by (c) GlaxoSmithKline Biologicals S. A., 2019 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | - |
dc.source | Articles publicats en revistes (ISGlobal) | - |
dc.subject.classification | Vacuna de la malària | - |
dc.subject.classification | Infants | - |
dc.subject.classification | Àfrica subsahariana | - |
dc.subject.other | Malaria vaccine | - |
dc.subject.other | Children | - |
dc.subject.other | Sub-Saharan Africa | - |
dc.title | Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2019-05-27T09:03:25Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 31012786 | - |
Appears in Collections: | Articles publicats en revistes (ISGlobal) |
Files in This Item:
File | Description | Size | Format | |
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GuerraMendozaY_Hum_Vaccin_Immunother_2019.pdf | 2.91 MB | Adobe PDF | View/Open |
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