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https://www.arca.fiocruz.br/handle/icict/25687
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
Affilliation
Hospital Clinico Universitario de Santiago de Compostela. Translational Pediatrics and Infectious Diseases. Department of Pediatrics. Santiago de Compostela, Spain
Santa Casa de São Paulo School of Medical Sciences. São Paulo, SP, Brazil
Instituto Hispalense de Pediatria de Sevilla. Sevilla, Spain
Hospital Virgen del Mar. Carretera del Mami a Viator. Almeria, Spain
Hospital Universitario de Mostoles. Móstoles, Madrid, Spain
Universidade Federal de São Paulo. São Paulo, SP, Brazil
Associação Obras Sociais Irma Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
GlaxoSmithKline. Amsterdam, The Netherlands
GlaxoSmithKline. Siena, Italy
GlaxoSmithKline. Siena, Italy
Santa Casa de São Paulo School of Medical Sciences. São Paulo, SP, Brazil
Instituto Hispalense de Pediatria de Sevilla. Sevilla, Spain
Hospital Virgen del Mar. Carretera del Mami a Viator. Almeria, Spain
Hospital Universitario de Mostoles. Móstoles, Madrid, Spain
Universidade Federal de São Paulo. São Paulo, SP, Brazil
Associação Obras Sociais Irma Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
GlaxoSmithKline. Amsterdam, The Netherlands
GlaxoSmithKline. Siena, Italy
GlaxoSmithKline. Siena, Italy
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.
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