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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Affiliation: | 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;2. Santa Casa de São Paulo School of Medical Sciences, Rua Doutor Cesário Motta Júnior, 61 - Vila Buarque, 01221-020 São Paulo, Brazil;3. Instituto Hispalense de Pediatria de Sevilla, Av. Manuel Siurot, 45, 41013 Sevilla, Spain;4. Hospital Virgen del Mar, Carretera del Mami a Viator, Almeria, Spain;5. Hospital Universitario de Mostoles, Río Júcar, s/n, 28935 Móstoles, Madrid, Spain;6. CRIE UNIFESP, Universidade Federal de Sao Paulo, R. Sena Madureira, 1500 - Vila Clementino, 04021-001São Paulo, Brazil;7. CPEC-Associação Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil;8. GSK, Huis Ter Heideweg 62, 3705 LZ Zeist, Amsterdam, The Netherlands;9. GSK, Via Fiorentina, 1, 53100 Siena, Italy |
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Abstract: | BackgroundThis 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.MethodsIn 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 2½–3½–5–11 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.Results754 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.ConclusionReduced infant schedules and catch-up series in children were immunogenic and safe, having the potential to widen 4CMenB vaccine coverage.FundingGlaxoSmithKline Biologicals SA. |
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Keywords: | 4CMenB vaccination Reduced doses Catch-up dose Infants Children AE" },{" #name" :" keyword" ," $" :{" id" :" k0035" }," $$" :[{" #name" :" text" ," _" :" adverse event CI" },{" #name" :" keyword" ," $" :{" id" :" k0045" }," $$" :[{" #name" :" text" ," _" :" confidence interval 4CMenB" },{" #name" :" keyword" ," $" :{" id" :" k0055" }," $$" :[{" #name" :" text" ," _" :" multi-component vaccine against MenB fHbp" },{" #name" :" keyword" ," $" :{" id" :" k0065" }," $$" :[{" #name" :" text" ," _" :" factor H binding protein GMT" },{" #name" :" keyword" ," $" :{" id" :" k0075" }," $$" :[{" #name" :" text" ," _" :" geometric mean titers hSBA" },{" #name" :" keyword" ," $" :{" id" :" k0085" }," $$" :[{" #name" :" text" ," _" :" serum bactericidal assay with human serum IMD" },{" #name" :" keyword" ," $" :{" id" :" k0095" }," $$" :[{" #name" :" text" ," _" :" invasive meningococcal disease LL" },{" #name" :" keyword" ," $" :{" id" :" k0105" }," $$" :[{" #name" :" text" ," _" :" lower limit MAS" },{" #name" :" keyword" ," $" :{" id" :" k0115" }," $$" :[{" #name" :" text" ," _" :" meningococcal antigen typing system Men" },{" #name" :" keyword" ," $" :{" id" :" k0125" }," $$" :[{" #name" :" text" ," _" :" meningococcal serotype NadA" },{" #name" :" keyword" ," $" :{" id" :" k0135" }," $$" :[{" #name" :" text" ," _" :" Neisserial adhesin A NHBA" },{" #name" :" keyword" ," $" :{" id" :" k0145" }," $$" :[{" #name" :" text" ," $$" :[{" #name" :" italic" ," _" :" Neisseria" },{" #name" :" __text__" ," _" :" heparin binding antigen PorA" },{" #name" :" keyword" ," $" :{" id" :" k0155" }," $$" :[{" #name" :" text" ," _" :" porin A protein SAE" },{" #name" :" keyword" ," $" :{" id" :" k0165" }," $$" :[{" #name" :" text" ," _" :" serious adverse event |
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