Immunogenicity and tolerability of a paediatric presentation of a virosomal hepatitis A vaccine in Chilean children aged 1-16 years

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dc.contributor.authorAbarca, Katia
dc.contributor.authorIbanez, Isabel
dc.contributor.authorde la Fuente, Pablo
dc.contributor.authorCerda, Leonardo
dc.contributor.authorBergeret, Jorge
dc.contributor.authorFroesner, Gert
dc.contributor.authorIbarra, Humberto
dc.date.accessioned2024-01-10T12:39:36Z
dc.date.available2024-01-10T12:39:36Z
dc.date.issued2011
dc.description.abstractWe assessed the immunogenicity of the paediatric dose of Epaxal (R) (0.25 mL) and the degrees of seroprotection achieved with the standard dose (0.5 mL) of Epaxal (R) or a dose of Havrix (R) Junior, in children in an open, randomised, controlled, multi-centre, parallel-group study conducted at 2 Chilean study centres. 360 healthy children and adolescents 12 months to <17 years of age not previously vaccinated against hepatitis A were enrolled. Subjects were randomised 2:2:1 to be vaccinated with either Epaxal (R) 0.25 mL [n = 146], Epaxal (R) 0.5 mL [n = 142] or Havrix (R) Junior In = 72] intramuscularly on Day 1 and after 6 months (26 weeks +/- 14 days). Primary end point was the proportion of subjects seroprotected (anti-HAV antibody concentration >= 10 mIU/mL) in the ATP population at Month 1. All vaccines elicited high seroprotection rates at Month 1: 95.7% with Epaxal (R) 0.25 mL, 99.3% with Epaxal (R) 0.5 mL and 94.0% with Havrix (R) Junior. After the booster vaccination, all subjects demonstrated 100% seroprotection with all vaccines. Antibody concentrations were similarly high in all age groups. The paediatric presentation achieved antibody concentrations similar to those achieved with the 0.5 mL dose across the entire age range, and there were no differences across the range of body weights from 9.0 kg to 82.7 kg. All study vaccines were well tolerated and there were no AEs leading to discontinuation. Thus, the paediatric 0.25 mL dose of Epaxal (R) fulfilled the primary objective of showing non-inferiority to the adult 0.5 mL dose and to Havrix (R) Junior, in terms of seroprotection rates achieved. The results show the paediatric dose of Epaxal (R) to be an attractive option when conducting childhood-vaccination programmes. (C) 2011 Elsevier Ltd. All rights reserved.
dc.description.funderCrucell Switzerland AG
dc.fechaingreso.objetodigital16-04-2024
dc.format.extent8 páginas
dc.fuente.origenWOS
dc.identifier.doi10.1016/j.vaccine.2011.09.095
dc.identifier.eissn1873-2518
dc.identifier.issn0264-410X
dc.identifier.pubmedidMEDLINE:21983354
dc.identifier.urihttps://doi.org/10.1016/j.vaccine.2011.09.095
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/77212
dc.identifier.wosidWOS:000297601200012
dc.information.autorucMedicina;Abarca K ;S/I;70281
dc.information.autorucMedicina;Ibañez I;S/I;1003924
dc.issue.numero48
dc.language.isoen
dc.nota.accesoContenido parcial
dc.pagina.final8862
dc.pagina.inicio8855
dc.publisherELSEVIER SCI LTD
dc.revistaVACCINE
dc.rightsacceso restringido
dc.subjectVaccination
dc.subjectHepatitis A
dc.subjectPaediatric
dc.subjectVirosomes
dc.subjectBOOSTER VACCINATION
dc.subjectYOUNG-CHILDREN
dc.subjectRISK-FACTORS
dc.subjectANTIBODIES
dc.subjectINFECTION
dc.subjectSAFETY
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleImmunogenicity and tolerability of a paediatric presentation of a virosomal hepatitis A vaccine in Chilean children aged 1-16 years
dc.typeartículo
dc.volumen29
sipa.codpersvinculados70281
sipa.codpersvinculados1003924
sipa.indexWOS
sipa.indexScopus
sipa.trazabilidadCarga SIPA;09-01-2024
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