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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.

Author information

1
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: federico.martinon.torres@sergas.es.
2
Santa Casa de São Paulo School of Medical Sciences, Rua Doutor Cesário Motta Júnior, 61 - Vila Buarque, 01221-020 São Paulo, Brazil. Electronic address: masafadi@uol.com.br.
3
Instituto Hispalense de Pediatria de Sevilla, Av. Manuel Siurot, 45, 41013 Sevilla, Spain. Electronic address: alfonsocarmona@ihppediatria.com.
4
Hospital Virgen del Mar, Carretera del Mami a Viator, Almeria, Spain. Electronic address: InfanteP@vithas.es.
5
Hospital Universitario de Mostoles, Río Júcar, s/n, 28935 Móstoles, Madrid, Spain. Electronic address: JCTEJEDOR@infonegocio.com.
6
CRIE UNIFESP, Universidade Federal de Sao Paulo, R. Sena Madureira, 1500 - Vila Clementino, 04021-001São Paulo, Brazil. Electronic address: lily.crie@epm.br.
7
CPEC-Associação Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil. Electronic address: edson@bahia.fiocruz.br.
8
GSK, Huis Ter Heideweg 62, 3705 LZ Zeist, Amsterdam, The Netherlands. Electronic address: ilhem.z.mensi@gsk.com.
9
GSK, Via Fiorentina, 1, 53100 Siena, Italy. Electronic address: marco.calabresi@gmail.com.
10
GSK, Via Fiorentina, 1, 53100 Siena, Italy. Electronic address: daniela.x.toneatto@gsk.com.

Abstract

BACKGROUND:

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 3½-5-11months 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.

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.

FUNDING:

GlaxoSmithKline Biologicals SA.

KEYWORDS:

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

PMID:
28533054
DOI:
10.1016/j.vaccine.2017.05.023
[Indexed for MEDLINE]
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