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dc.contributor.authorDiez-Domingo, Javier-
dc.contributor.authorde Martino, Maurizio-
dc.contributor.authorGarcia-Sicilia Lopez, Jose-
dc.contributor.authorZuccotti, Gian Vincenzo-
dc.contributor.authorIcardi, Giancarlo-
dc.contributor.authorVillani, Alberto-
dc.contributor.authorMoreno-Perez, David-
dc.contributor.authorMéndez Hernández, María-
dc.contributor.authorÁlvarez Aldeán, Javier-
dc.contributor.authorMateen, Ahmed Abdul-
dc.contributor.authorEnweonye, Igwebuike-
dc.contributor.authorde Rooij, Richard-
dc.contributor.authorChandra, Richa-
dc.identifier.citationDiez-Domingo J, de Martino M, Lopez JG, Zuccotti GV, Icardi G, Villani A, et al. Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications. Int. J. Infect. Dis. 2016 ; 49:171-8es_ES
dc.identifier.issn1878-3511 (Online)es_ES
dc.identifier.issn1201-9712 (Print)es_ES
dc.descriptionJournal Article;es_ES
dc.description.abstractBACKGROUND This descriptive, non-comparative, phase III study evaluated the safety and tolerability of cell culture-derived (TIVc) and egg-derived (TIV) seasonal influenza vaccines in children at risk of influenza-related complications. METHODS Four hundred and thirty subjects were randomized 2:1 to TIVc or TIV. Subjects aged 3 to <9 years received one dose (if previously vaccinated, n=89) or two doses (if not previously vaccinated, n=124) of the study vaccines; the 9 to <18-year-olds (n=213) received one dose. Reactogenicity was assessed for 7 days after vaccination; safety was monitored for 6 months. RESULTS After any vaccination, the most frequently reported solicited local adverse event (AE) was tenderness/pain (TIVc 44%, 66%, 53% and TIV 56%, 51%, 65% in the age groups 3 to <6 years, 6 to <9 years, and 9 to <18 years, respectively) and the systemic AE was irritability (22% TIVc, 24% TIV) in 3 to <6-year-olds and headache in 6 to <9-year-olds (20% TIVc, 13% TIV) and 9 to <18-year-olds (21% TIVc, 26% TIV). There were no cases of severe fever (≥40°C). No vaccine-related serious AEs were noted. New onset of chronic disease was reported in ≤1% of subjects. CONCLUSION TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).es_ES
dc.description.sponsorshipThis study was sponsored by Novartis Vaccines and Diagnostics, Inc.es_ES
dc.relation.ispartofInternational Journal of Infectious Diseases : IJID : official publication of the International Society for Infectious Diseaseses_ES
dc.subjectCell culture-derivedes_ES
dc.subjectInfluenza vaccinees_ES
dc.subjectAt-risk childrenes_ES
dc.subjectVacunas contra la Influenzaes_ES
dc.subjectEstaciones del añoes_ES
dc.subject.meshMedical Subject Headings::Chemicals and Drugs::Complex Mixtures::Biological Agents::Vaccines::Viral Vaccines::Influenza Vaccineses_ES
dc.subject.meshMedical Subject Headings::Named Groups::Persons::Age Groups::Childes_ES
dc.subject.meshMedical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Orthomyxoviridae Infections::Influenza, Humanes_ES
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::Vaccinationes_ES
dc.subject.meshMedical Subject Headings::Check Tags::Malees_ES
dc.subject.meshMedical Subject Headings::Check Tags::Femalees_ES
dc.subject.meshMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humanses_ES
dc.subject.meshMedical Subject Headings::Health Care::Environment and Public Health::Environment::Meteorological Concepts::Atmosphere::Climate::Seasonses_ES
dc.titleSafety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications.es_ES
dc.rights.accessRightsAcceso abiertoes_ES
dc.contributor.authoraffiliation[Diez-Domingo,J] Vaccine Research Department. FISABIO-Public Health, Valencia, Spain. [de Martino,M] Anna Meyer Children's University Hospital, Florence, Italy. [García-Sicilia Lopez,J] Hospital Universitario HM Sanchinarro, Madrid, Spain. [Zuccotti,GV] Department of Paediatrics, Children Hospital V. Buzzi, University of Milan, Milan, Italy. [Icardi,G] Department of Health Sciences, University of Genoa and I.R.C.C.S. University Hospital, San Martino-IST National Institute for Cancer Research, Genoa, Italy. [Villani,A] Department of General Paediatrics and Infectious Diseases, Bambino Gesù Children Hospital, Rome, Italy. [Moreno-Perez,D] Paediatrics Department, Hospital Materno Infantil, Málaga, Spain. [Méndez Hernández,M] Hospital Germans Trias i Pujol, Barcelona, Spain. [Álvarez Aldeán,J] Agencia Sanitaria Hospital Costa del Sol, Marbella, Spain. [Mateen,AA] Novartis Pharmaceuticals Canada Inc., 385, Bouchard Blvd, Dorval, Quebec H9S 1A9, Canada. [Enweonye,I; de Rooij,R] Novartis Pharma BV, Amsterdam, Netherlands. [Chandra,R] Novartis Vaccines and Diagnostics Inc., Cambridge, Massachusetts, USA.es_ES
dc.type.subtypeArtículo originales_ES
Appears in Collections:01- Artículos - APES Costa del Sol
01- Artículos - Hospital Regional de Málaga

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