Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial

Detalhes bibliográficos
Autor(a) principal: Torres, Federico Martinón
Data de Publicação: 2017
Outros Autores: Safadi, Marco Aurelio Palazzi, Martinez, Alfonso Carmona, Marquez, Pilar Infante, Torres, Juan Carlos Tejedor, Weckx, Lily Yin, Moreira Junior, Edson Duarte, Mensi, Ilhem, Calabresi, Marco, Toneatto, Daniela
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/25687
Resumo: Novartis Vaccines and Diagnostics, now GlaxoSmithKline Biologicals SA
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spelling Torres, Federico MartinónSafadi, Marco Aurelio PalazziMartinez, Alfonso CarmonaMarquez, Pilar InfanteTorres, Juan Carlos TejedorWeckx, Lily YinMoreira Junior, Edson DuarteMensi, IlhemCalabresi, MarcoToneatto, Daniela2018-04-09T17:16:12Z2018-04-09T17:16:12Z2017TORRES, F. M. et al. Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial. Vaccine, v. 35, p. 3548–3557, 2017.0264-410Xhttps://www.arca.fiocruz.br/handle/icict/2568710.1016/j.vaccine.2017.05.023Novartis Vaccines and Diagnostics, now GlaxoSmithKline Biologicals SAHospital Clinico Universitario de Santiago de Compostela. Translational Pediatrics and Infectious Diseases. Department of Pediatrics. Santiago de Compostela, SpainSanta Casa de São Paulo School of Medical Sciences. São Paulo, SP, BrazilInstituto Hispalense de Pediatria de Sevilla. Sevilla, SpainHospital Virgen del Mar. Carretera del Mami a Viator. Almeria, SpainHospital Universitario de Mostoles. Móstoles, Madrid, SpainUniversidade Federal de São Paulo. São Paulo, SP, BrazilAssociação Obras Sociais Irma Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilGlaxoSmithKline. Amsterdam, The NetherlandsGlaxoSmithKline. Siena, ItalyGlaxoSmithKline. Siena, ItalyThis study evaluated the immunogenicity and safety of a licensed meningococcal serogroup B vaccine (4CMenB) administered alone according to reduced schedules in infants or catch-up series in children. Methods: In this open-label, multicentre, phase 3b study (NCT01339923), infants randomised 1:1:1 received 4CMenB: 2 + 1 doses at 3½–5–11 months or 6–8–11 months of age, 3 + 1 doses at ages 2½–3 ½–5–11 months. Children aged 2–10 years received 2 catch-up doses administered 2 months apart. Immune responses were measured by hSBA assays against 4 strains specific for vaccine components fHbp, NadA, PorA and NHBA. Sufficiency of immune responses was defined in groups with 2 + 1 doses schedules as a lower limit 70% for the 97.5% confidence interval of the percentage of infants with hSBA titres 4, 1 month post-dose 2 for fHbp, NadA, PorA. Adverse events were collected for 7 days post-vaccination; serious adverse events (SAEs) throughout the study. Results: 754 infants and 404 children were enrolled. Post-primary vaccination, 98–100% of infants across all groups developed hSBA titres 4 for fHbp, NadA, PorA, and 48–77% for NHBA. Sufficiency of immune responses in infants receiving 2 + 1 schedules was demonstrated for fHbp, NadA, PorA after 2 doses of 4CMenB, as pre-specified criteria were met. Following receipt of 2 catch-up doses, 95–99% of children developed hSBA titres 4 for 4CMenB components. Similar safety profiles were observed across groups. A total of 45 SAEs were reported, 3 of which were related to vaccination. Conclusion: Reduced infant schedules and catch-up series in children were immunogenic and safe, having the potential to widen 4CMenB vaccine coverage.engElsevierVacinaçãoDoses reduzidasDose de recuperaçãoBebesCrianças4CMenB vaccinationReduced dosesCatch-up doseInfantsChildrenReduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/25687/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALTorres FM Reduced schedules of 4CMenB vaccine....pdfTorres FM Reduced schedules of 4CMenB vaccine....pdfapplication/pdf1521288https://www.arca.fiocruz.br/bitstream/icict/25687/2/Torres%20FM%20Reduced%20schedules%20of%204CMenB%20vaccine....pdf89c30d9b6dcf212dd82f390430b210beMD52TEXTTorres FM Reduced schedules of 4CMenB vaccine....pdf.txtTorres FM Reduced schedules of 4CMenB vaccine....pdf.txtExtracted texttext/plain42828https://www.arca.fiocruz.br/bitstream/icict/25687/3/Torres%20FM%20Reduced%20schedules%20of%204CMenB%20vaccine....pdf.txtd1056f28635a312ca9c1b6c318f812eeMD53icict/256872023-03-15 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dc.title.pt_BR.fl_str_mv Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial
title Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial
spellingShingle Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial
Torres, Federico Martinón
Vacinação
Doses reduzidas
Dose de recuperação
Bebes
Crianças
4CMenB vaccination
Reduced doses
Catch-up dose
Infants
Children
title_short Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial
title_full Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial
title_fullStr Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial
title_full_unstemmed Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial
title_sort Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial
author Torres, Federico Martinón
author_facet Torres, Federico Martinón
Safadi, Marco Aurelio Palazzi
Martinez, Alfonso Carmona
Marquez, Pilar Infante
Torres, Juan Carlos Tejedor
Weckx, Lily Yin
Moreira Junior, Edson Duarte
Mensi, Ilhem
Calabresi, Marco
Toneatto, Daniela
author_role author
author2 Safadi, Marco Aurelio Palazzi
Martinez, Alfonso Carmona
Marquez, Pilar Infante
Torres, Juan Carlos Tejedor
Weckx, Lily Yin
Moreira Junior, Edson Duarte
Mensi, Ilhem
Calabresi, Marco
Toneatto, Daniela
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Torres, Federico Martinón
Safadi, Marco Aurelio Palazzi
Martinez, Alfonso Carmona
Marquez, Pilar Infante
Torres, Juan Carlos Tejedor
Weckx, Lily Yin
Moreira Junior, Edson Duarte
Mensi, Ilhem
Calabresi, Marco
Toneatto, Daniela
dc.subject.other.pt_BR.fl_str_mv Vacinação
Doses reduzidas
Dose de recuperação
Bebes
Crianças
topic Vacinação
Doses reduzidas
Dose de recuperação
Bebes
Crianças
4CMenB vaccination
Reduced doses
Catch-up dose
Infants
Children
dc.subject.en.pt_BR.fl_str_mv 4CMenB vaccination
Reduced doses
Catch-up dose
Infants
Children
description Novartis Vaccines and Diagnostics, now GlaxoSmithKline Biologicals SA
publishDate 2017
dc.date.issued.fl_str_mv 2017
dc.date.accessioned.fl_str_mv 2018-04-09T17:16:12Z
dc.date.available.fl_str_mv 2018-04-09T17:16:12Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv TORRES, F. M. et al. Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial. Vaccine, v. 35, p. 3548–3557, 2017.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/25687
dc.identifier.issn.pt_BR.fl_str_mv 0264-410X
dc.identifier.doi.none.fl_str_mv 10.1016/j.vaccine.2017.05.023
identifier_str_mv TORRES, F. M. et al. Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial. Vaccine, v. 35, p. 3548–3557, 2017.
0264-410X
10.1016/j.vaccine.2017.05.023
url https://www.arca.fiocruz.br/handle/icict/25687
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
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