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Vaccine. 2017 Jun 16;35(28):3548-3557. doi: 10.1016/j.vaccine.2017.05.023. Epub 2017 May 19.

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.

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Translational Pediatrics and Infectious Diseases, Department of Pediatrics, Hospital Clinico Universitario de Santiago de Compostela, A Choupana, s/n, 15706 Santiago de Compostela, Spain. Electronic address:
Santa Casa de São Paulo School of Medical Sciences, Rua Doutor Cesário Motta Júnior, 61 - Vila Buarque, 01221-020 São Paulo, Brazil. Electronic address:
Instituto Hispalense de Pediatria de Sevilla, Av. Manuel Siurot, 45, 41013 Sevilla, Spain. Electronic address:
Hospital Virgen del Mar, Carretera del Mami a Viator, Almeria, Spain. Electronic address:
Hospital Universitario de Mostoles, Río Júcar, s/n, 28935 Móstoles, Madrid, Spain. Electronic address:
CRIE UNIFESP, Universidade Federal de Sao Paulo, R. Sena Madureira, 1500 - Vila Clementino, 04021-001São Paulo, Brazil. Electronic address:
CPEC-Associação Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil. Electronic address:
GSK, Huis Ter Heideweg 62, 3705 LZ Zeist, Amsterdam, The Netherlands. Electronic address:
GSK, Via Fiorentina, 1, 53100 Siena, Italy. Electronic address:
GSK, Via Fiorentina, 1, 53100 Siena, Italy. Electronic address:



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.


In this open-label, multicentre, phase 3b study (NCT01339923), infants randomised 1:1:1 received 4CMenB: 2+1 doses at 3½-5-11months or 6-8-11months of age, 3+1 doses at ages 2½-3½-5-11months. Children aged 2-10years received 2 catch-up doses administered 2months 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, 1month post-dose 2 for fHbp, NadA, PorA. Adverse events were collected for 7days post-vaccination; serious adverse events (SAEs) throughout the study.


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.


Reduced infant schedules and catch-up series in children were immunogenic and safe, having the potential to widen 4CMenB vaccine coverage.


GlaxoSmithKline Biologicals SA.


4CMenB vaccination; Catch-up dose; Children; Infants; Reduced doses

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