Author | Torres, Federico Martinón | |
Author | Safadi, Marco Aurelio Palazzi | |
Author | Martinez, Alfonso Carmona | |
Author | Marquez, Pilar Infante | |
Author | Torres, Juan Carlos Tejedor | |
Author | Weckx, Lily Yin | |
Author | Moreira Junior, Edson Duarte | |
Author | Mensi, Ilhem | |
Author | Calabresi, Marco | |
Author | Toneatto, Daniela | |
Access date | 2018-04-09T17:16:12Z | |
Available date | 2018-04-09T17:16:12Z | |
Document date | 2017 | |
Citation | 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. | pt_BR |
ISSN | 0264-410X | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/25687 | |
Sponsorship | Novartis Vaccines and Diagnostics, now GlaxoSmithKline Biologicals SA | pt_BR |
Language | eng | pt_BR |
Publisher | Elsevier | pt_BR |
Rights | open access | pt_BR |
Subject in Portuguese | Vacinação | pt_BR |
Subject in Portuguese | Doses reduzidas | pt_BR |
Subject in Portuguese | Dose de recuperação | pt_BR |
Subject in Portuguese | Bebes | pt_BR |
Subject in Portuguese | Crianças | pt_BR |
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 | pt_BR |
Type | Article | pt_BR |
DOI | 10.1016/j.vaccine.2017.05.023 | |
Abstract | This 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. | pt_BR |
Affilliation | Hospital Clinico Universitario de Santiago de Compostela. Translational Pediatrics and Infectious Diseases. Department of Pediatrics. Santiago de Compostela, Spain | pt_BR |
Affilliation | Santa Casa de São Paulo School of Medical Sciences. São Paulo, SP, Brazil | pt_BR |
Affilliation | Instituto Hispalense de Pediatria de Sevilla. Sevilla, Spain | pt_BR |
Affilliation | Hospital Virgen del Mar. Carretera del Mami a Viator. Almeria, Spain | pt_BR |
Affilliation | Hospital Universitario de Mostoles. Móstoles, Madrid, Spain | pt_BR |
Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brazil | pt_BR |
Affilliation | Associação Obras Sociais Irma Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil | pt_BR |
Affilliation | GlaxoSmithKline. Amsterdam, The Netherlands | pt_BR |
Affilliation | GlaxoSmithKline. Siena, Italy | pt_BR |
Affilliation | GlaxoSmithKline. Siena, Italy | pt_BR |
Subject | 4CMenB vaccination | pt_BR |
Subject | Reduced doses | pt_BR |
Subject | Catch-up dose | pt_BR |
Subject | Infants | pt_BR |
Subject | Children | pt_BR |