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Research Paper

A phase II randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II)

Effects of variations of the OMV and protein content on immunogenicity and reactogenicity

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Pages 2005-2014 | Received 23 Dec 2013, Accepted 13 May 2014, Published online: 11 Jul 2014

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Read on this site (9)

Véronique Abitbol, Woo-Yun Sohn, Michael Horn & Marco Aurelio P. Safadi. (2023) Safety and immunogenicity of co-administered meningococcal serogroup B (4CMenB) vaccine: A literature review. Human Vaccines & Immunotherapeutics 19:2.
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Viola Viviani, Alessia Biolchi & Mariagrazia Pizza. (2022) Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Review of Vaccines 21:5, pages 645-658.
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Timo Vesikari, Jerzy Brzostek, Anitta Ahonen, Marita Paassilta, Ewa Majda-Stanislawska, Leszek Szenborn, Miia Virta, Robert Clifford, Teresa Jackowska, Murray Kimmel, Ilaria Bindi, Pavitra Keshavan, Paola Pedotti & Daniela Toneatto. (2021) Immunogenicity and safety of different schedules of the meningococcal ABCWY vaccine, with assessment of long-term antibody persistence and booster responses – results from two phase 2b randomized trials in adolescents. Human Vaccines & Immunotherapeutics 17:11, pages 4689-4700.
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Omar Rossi, Francesco Citiulo & Francesca Mancini. (2021) Outer membrane vesicles: moving within the intricate labyrinth of assays that can predict risks of reactogenicity in humans. Human Vaccines & Immunotherapeutics 17:2, pages 601-613.
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Jan Dolhain, Winnie Janssens, Vasundhara Dindore & Attila Mihalyi. (2020) Infant vaccine co-administration: review of 18 years of experience with GSK’s hexavalent vaccine co-administered with routine childhood vaccines. Expert Review of Vaccines 19:5, pages 419-443.
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Rino Rappuoli, Mariagrazia Pizza, Vega Masignani & Kumaran Vadivelu. (2018) Meningococcal B vaccine (4CMenB): the journey from research to real world experience. Expert Review of Vaccines 17:12, pages 1111-1121.
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Daniela Toneatto, Mariagrazia Pizza, Vega Masignani & Rino Rappuoli. (2017) Emerging experience with meningococcal serogroup B protein vaccines. Expert Review of Vaccines 16:5, pages 433-451.
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Kate L Seib, Maria Scarselli, Maurizio Comanducci, Daniela Toneatto & Vega Masignani. (2015) Neisseria meningitidis factor H-binding protein fHbp: a key virulence factor and vaccine antigen. Expert Review of Vaccines 14:6, pages 841-859.
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Roman Prymula, Susanna Esposito, Gian Vincenzo Zuccotti, Fang Xie, Daniela Toneatto, Igor Kohl & Peter M Dull. (2014) A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I). Human Vaccines & Immunotherapeutics 10:7, pages 1993-2004.
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Articles from other publishers (25)

Leila Sadeghi, Elham Mohit, Samaneh Moallemi, Fatemeh Maghsood Ahmadi & Azam Bolhassani. (2023) Recent advances in various bio-applications of bacteria-derived outer membrane vesicles. Microbial Pathogenesis 185, pages 106440.
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Viola Viviani, Adele Fantoni, Sara Tomei, Sara Marchi, Enrico Luzzi, Margherita Bodini, Alessandro Muzzi, Marzia M. Giuliani, Domenico Maione, Jeremy P. Derrick, Isabel Delany, Mariagrazia Pizza, Alessia Biolchi & Erika Bartolini. (2023) OpcA and PorB are novel bactericidal antigens of the 4CMenB vaccine in mice and humans. npj Vaccines 8:1.
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David S. Stephens, Dan M. Granoff, Andrew J. Pollard & Lee H. Harrison. 2023. Plotkin's Vaccines. Plotkin's Vaccines 690 710.e7 .
Michael D. Decker, Barbara J. Howe, David P. Greenberg & Kathryn M. Edwards. 2023. Plotkin's Vaccines. Plotkin's Vaccines 225 247.e13 .
Kimberly Davis, Marta Valente Pinto, Nick J Andrews, David Goldblatt, Ray Borrow, Helen Findlow, Jo Southern, Jo Partington, Emma Plested, Sima Patel, Ann Holland, Mary Matheson, Anna England, Bassam Hallis, Elizabeth Miller & Matthew D Snape. (2021) Immunogenicity of the UK group B meningococcal vaccine (4CMenB) schedule against groups B and C meningococcal strains (Sched3): outcomes of a multicentre, open-label, randomised controlled trial. The Lancet Infectious Diseases 21:5, pages 688-696.
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Daniel O’Connor, Marta Valente Pinto, Dylan Sheerin, Adriana Tomic, Ruth E Drury, Samuel Channon‐Wells, Ushma Galal, Christina Dold, Hannah Robinson, Simon Kerridge, Emma Plested, Harri Hughes, Lisa Stockdale, Manish Sadarangani, Matthew D Snape, Christine S Rollier, Michael Levin & Andrew J Pollard. (2020) Gene expression profiling reveals insights into infant immunological and febrile responses to group B meningococcal vaccine. Molecular Systems Biology 16:11.
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Ali A Raba & Ibraheem Krebit. (2020) Definite bacterial infection in recently vaccinated febrile infants. Journal of Paediatrics and Child Health 56:6, pages 889-892.
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Gillian Campbell, Ruth M Bland & Scott J Hendry. (2018) Fever after meningococcal B immunisation: A case series. Journal of Paediatrics and Child Health 55:8, pages 932-937.
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Gaston De Serres, Marie-Noëlle Billard, Marie-Claude Gariépy, Marie-Claude Roy, François D. Boucher, Hélène Gagné, Sylvie Belley, Eveline Toth, Monique Landry & Danuta M. Skowronski. (2019) Nephrotic syndrome following four-component meningococcal B vaccination: Epidemiologic investigation of a surveillance signal. Vaccine 37:35, pages 4996-5002.
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Joseline Guetsop Zafack, Alexandre Bureau, Danuta M Skowronski & Gaston De Serres. (2019) Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open 9:5, pages e026953.
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T. Tenenbaum, W. Hellenbrand & H. Schroten. (2019) Impfstoffe gegen Meningokokken für das KindesalterVaccines against meningococci for children. Monatsschrift Kinderheilkunde 167:3, pages 196-205.
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Lee H. Harrison. 2019. Vaccinations. Vaccinations 105 129 .
Gaston De Serres, Marie-Noëlle Billard, Marie-Claude Gariépy, Isabelle Rouleau, Eveline Toth, Monique Landry, Nicole Boulianne, Hélène Gagné, Vladimir Gilca, Geneviève Deceuninck, Manale Ouakki & Danuta M Skowronski. (2018) Short-term safety of 4CMenB vaccine during a mass meningococcal B vaccination campaign in Quebec, Canada. Vaccine 36:52, pages 8039-8046.
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Mercedes Macias Parra, Angela Gentile, Jorge Alejandro Vazquez Narvaez, Alejandro Capdevila, Angel Minguez, Monica Carrascal, Arnold Willemsen, Chiranjiwi Bhusal & Daniela Toneatto. (2018) Immunogenicity and safety of the 4CMenB and MenACWY-CRM meningococcal vaccines administered concomitantly in infants: A phase 3b, randomized controlled trial. Vaccine 36:50, pages 7609-7617.
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Dirk Mentzer, Doris Oberle & Brigitte Keller-Stanislawski. (2018) Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016. Eurosurveillance 23:17.
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Maria Elena Flacco, Lamberto Manzoli, Annalisa Rosso, Carolina Marzuillo, Mauro Bergamini, Armando Stefanati, Rosario Cultrera, Paolo Villari, Walter Ricciardi, John P A Ioannidis & Despina G Contopoulos-Ioannidis. (2018) Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: a systematic review and meta-analysis. The Lancet Infectious Diseases 18:4, pages 461-472.
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Dan M. Granoff, Andrew J. Pollard & Lee H. Harrison. 2018. Plotkin's Vaccines. Plotkin's Vaccines 644 662.e6 .
Federico Martinón-Torres, Marco Aurelio P. Safadi, Alfonso Carmona Martinez, Pilar Infante Marquez, Juan Carlos Tejedor Torres, Lily Yin Weckx, Edson Duarte MoreiraJuniorJunior, Ilhem Mensi, Marco Calabresi & Daniela Toneatto. (2017) 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 35:28, pages 3548-3557.
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Marco Aurelio P. Safadi, Federico Martinon-Torres, Lily Yin Weckx, Edson Duarte MoreiraJuniorJunior, Eduardo Jorge da Fonseca Lima, Ilhem Mensi, Marco Calabresi & Daniela Toneatto. (2017) 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 35:16, pages 2052-2059.
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K.M. Damer & C.M. Jung. 2016. A Worldwide Yearly Survey of New Data in Adverse Drug Reactions. A Worldwide Yearly Survey of New Data in Adverse Drug Reactions 307 334 .
Wiebke Hellenbrand, Judith Koch, Thomas Harder, Christian Bogdan, Ulrich Heininger, Tobias Tenenbaum, Martin Terhardt, Ulrich Vogel, Ole Wichmann & Rüdiger von Kries. (2015) Background Paper for the update of meningococcal vaccination recommendations in Germany: use of the serogroup B vaccine in persons at increased risk for meningococcal diseaseWissenschaftliche Begründung zur Aktualisierung der Meningokokken-Impfempfehlung – Anwendung des Meningokokken-B-Impfstoffs bei Personen mit erhöhtem Risiko für Meningokokken-Erkrankungen. Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz 58:11-12, pages 1314-1343.
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Timo Vesikari, Roman Prymula, Elizabeth Merrall, Igor Kohl, Daniela Toneatto & Peter M. Dull. (2015) Meningococcal serogroup B vaccine (4CMenB): Booster dose in previously vaccinated infants and primary vaccination in toddlers and two-year-old children. Vaccine 33:32, pages 3850-3858.
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Stan L. Block, Leszek Szenborn, Wendy Daly, Teresa Jackowska, Diego D’Agostino, Linda Han, Peter M. Dull & Igor Smolenov. (2015) A comparative evaluation of two investigational meningococcal ABCWY vaccine formulations: Results of a phase 2 randomized, controlled trial. Vaccine 33:21, pages 2500-2510.
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Christine Robin, Florence Beckerich & Catherine Cordonnier. (2015) Immunization in cancer patients: Where we stand. Pharmacological Research 92, pages 23-30.
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Susanna Esposito, Claudia Tagliabue & Samantha Bosis. (2015) Meningococcal B Vaccination (4CMenB) in Infants and Toddlers. Journal of Immunology Research 2015, pages 1-6.
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