Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial

Detalhes bibliográficos
Autor(a) principal: Safadi, Marco Aurelio Palazzi
Data de Publicação: 2017
Outros Autores: Torres, Federico Martinon, Weckx, Lily Yin, Moreira Junior, Edson Duarte, Lima, Eduardo Jorge da Fonseca, 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/25564
Resumo: Novartis Vaccines and Diagnostics, Inc., now GlaxoSmithKline Biologicals SA.
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spelling Safadi, Marco Aurelio PalazziTorres, Federico MartinonWeckx, Lily YinMoreira Junior, Edson DuarteLima, Eduardo Jorge da FonsecaMensi, IlhemCalabresi, MarcoToneatto, Daniela2018-04-02T18:42:50Z2018-04-02T18:42:50Z2017SAFADI, M. A. P. et al. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. Vaccine, v. 35, p. 2052–2059, 2017.0264-410Xhttps://www.arca.fiocruz.br/handle/icict/2556410.1016/j.vaccine.2017.03.002Novartis Vaccines and Diagnostics, Inc., now GlaxoSmithKline Biologicals SA.Santa Casa de São Paulo. School of Medical Sciences and CDEC. São Paulo, SP, BrazilHospital Clinico Universitario de Santiago de Compostela. Santiago de Compostela, SpainUniversidade Federal de São Paulo. São Paulo, SP, BrasilAssociação Obras Sociais Irma Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilInstituto de Medicina Integral Professor Fernando Figueira. Boa Vista Recife, PE, BrasilGSK. Amsterdam, The NetherlandsGSK. Siena, ItalyGSK. Siena, ItalyAfter implementation of routine infant MenC vaccination, MenB remains a serious cause of meningococcal disease, yet to be targeted by vaccination programs in several countries. This study (NCT01339923) investigated the immunogenicity and safety of MenC CRM-conjugated vaccine (MenC-CRM) concomitantly administered with MenB vaccine (4CMenB). Methods: Infants (N = 251) were randomised 1:1 to receive 4CMenB and MenC-CRM (Group 1) or MenCCRM alone (Group 2) at 3 and 5 months (M3, M5) and a booster at 12 months of age (M12), and pneumococcal vaccine at M3, M5, M7, M12. Antibody responses to meningococcal vaccines were measured at M3, M6, M12, and M13. Non-inferiority of MenC-CRM response in Group 1 vs Group 2 was demonstrated at M6 and M13, if the lower limit of the 95% confidence interval (LL95%CI) of the difference in percentage of infants with hSBA titres 1:8 was > 10%. Sufficiency of MenB response was achieved if LL95% CI of the percentage of infants with hSBA titres 1:4 against fHbp, NadA and PorA strains was 70% at M6 or 75% at M13. Adverse events (AEs) were collected for 7 days post-vaccination, and serious AEs (SAEs) and medically attended AEs throughout the study. Results: Non-inferiority of MenC response in Group 1 vs Group 2 (LL95%CI 6.4% [M6]; 5.2% [M13]) and sufficiency of MenB response in Group 1 (LL95%CI 92%, 90%, 89% [M6]; 97%, 92%, 93% [M13] against fHbp, NadA, PorA, respectively) were demonstrated. Higher rates of mild to moderate solicited AEs were reported in Group 1. Unsolicited AEs and SAEs incidences were similar across groups. Conclusions: Concomitant administration of MenC-CRM and 4CMenB in infants was immunogenic, resulting in non-inferior responses against MenC compared to MenC-CRM alone and demonstration of sufficient immune response to MenB, after primary and booster vaccination. Reactogenicity was higher for concomitant vaccines administration, but no safety concerns were identified.engElsevier4CMenBMenC-CRMBebêsImunogenicidadeSegurança4CMenBMenC-CRMInfantsImmunogenicitySafetyImmunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled 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/25564/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALSafadi MA Immunogenicity and safety of concomitant ....pdfSafadi MA Immunogenicity and safety of concomitant 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dc.title.pt_BR.fl_str_mv Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial
title Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial
spellingShingle Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial
Safadi, Marco Aurelio Palazzi
4CMenB
MenC-CRM
Bebês
Imunogenicidade
Segurança
4CMenB
MenC-CRM
Infants
Immunogenicity
Safety
title_short Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial
title_full Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial
title_fullStr Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial
title_full_unstemmed Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial
title_sort Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial
author Safadi, Marco Aurelio Palazzi
author_facet Safadi, Marco Aurelio Palazzi
Torres, Federico Martinon
Weckx, Lily Yin
Moreira Junior, Edson Duarte
Lima, Eduardo Jorge da Fonseca
Mensi, Ilhem
Calabresi, Marco
Toneatto, Daniela
author_role author
author2 Torres, Federico Martinon
Weckx, Lily Yin
Moreira Junior, Edson Duarte
Lima, Eduardo Jorge da Fonseca
Mensi, Ilhem
Calabresi, Marco
Toneatto, Daniela
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Safadi, Marco Aurelio Palazzi
Torres, Federico Martinon
Weckx, Lily Yin
Moreira Junior, Edson Duarte
Lima, Eduardo Jorge da Fonseca
Mensi, Ilhem
Calabresi, Marco
Toneatto, Daniela
dc.subject.other.pt_BR.fl_str_mv 4CMenB
MenC-CRM
Bebês
Imunogenicidade
Segurança
topic 4CMenB
MenC-CRM
Bebês
Imunogenicidade
Segurança
4CMenB
MenC-CRM
Infants
Immunogenicity
Safety
dc.subject.en.pt_BR.fl_str_mv 4CMenB
MenC-CRM
Infants
Immunogenicity
Safety
description Novartis Vaccines and Diagnostics, Inc., now GlaxoSmithKline Biologicals SA.
publishDate 2017
dc.date.issued.fl_str_mv 2017
dc.date.accessioned.fl_str_mv 2018-04-02T18:42:50Z
dc.date.available.fl_str_mv 2018-04-02T18:42:50Z
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 SAFADI, M. A. P. et al. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. Vaccine, v. 35, p. 2052–2059, 2017.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/25564
dc.identifier.issn.pt_BR.fl_str_mv 0264-410X
dc.identifier.doi.none.fl_str_mv 10.1016/j.vaccine.2017.03.002
identifier_str_mv SAFADI, M. A. P. et al. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. Vaccine, v. 35, p. 2052–2059, 2017.
0264-410X
10.1016/j.vaccine.2017.03.002
url https://www.arca.fiocruz.br/handle/icict/25564
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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