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Título :	A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonalinfluenza vaccine at two dosages in children 6 to 35 months of age
Creador:	Pavia Ruz N.
Nivel de acceso:	Open access
Palabras clave :	Anticuerpos Antivirales - sangre Preescolar Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos - epidemiología Femenino Pruebas de Inhibición de Hemaglutinación Humanos Lactante Vacunas contra la Influenza - administración & dosificación Vacunas contra la Influenza - efectos adversos Gripe Humana - inmunología Gripe Humana - prevención y control Masculino Vacunación - métodos Vacunas de Productos Inactivados - administración & dosificación Vacunas de Productos Inactivados - efectos adversos Vacunas de Productos Inactivados - inmunología Antibodies, Viral - blood Child, Preschool Drug-Related Side Effects and Adverse Reactions - epidemiology Female Hemagglutination Inhibition Tests Humans Infant Influenza Vaccines - administration & dosage Influenza Vaccines - adverse effects Influenza Vaccines - immunology Influenza, Human - immunology Influenza, Human - prevention & control Male Vaccination - methods Vaccines, Inactivated - administration & dosage Vaccines, Inactivated - adverse effects Vaccines, Inactivated - immunology Children Immunogenicity Influenza Trivalent inactivated Vaccine
Descripción :	The trivalent inactivated influenza vaccine Fluarixâ„¢ is licensed in the US for adults and children from 3 years old. This randomized observer-blind study (NCT00764790) evaluated Fluarixâ„¢ at two doses; 0.25 ml (Flu-25) and 0.5 ml (Flu-50) in children aged 6-35 months. The primary objective was to demonstrate immunogenic non-inferiority vs. a control vaccine (Fluzone®; 0.25 ml). Children received Flu-25 (n = 1107), Flu-50 (n = 1106) or control vaccine (n = 1104) at Day 0 and for unprimed children, also on Day 28. Serum hemagglutination-inhibition titers were determined pre-vaccination and at Day 28 (primed) or Day 56 (un-primed). Non-inferiority was assessed by post-vaccination geometric mean titer (GMT) ratio, (upper 95% confidence interval [CI] ≤ 1.5) and difference in seroconversion rate (upper 95% CI ≤ 10%). Reactogenicity/ safety was monitored. The immune response to Flu-50 met all regulatory criteria. Indicated by adjusted GMT ratios [with 95% CI], the criteria for non-inferiority of Flu-50 vs. control vaccine were reached for the B/Florida strain (1.13 [1.01-1.25]) but not for the A/Brisbane/H1N1 (1.74 [1.54-1.98]) or A/Uruguay/H3N2 (1.72 [1.57-1.89]) strains. In children aged 18-35 months similar immune responses were observed for Flu-50 and the control vaccine. Flu-50 induced a higher response than Flu-25 for all strains. Temperature (≥37.5°C) was reported in 6.2%, 6.4%, and 6.6% of the Flu-25, Flu-50, and control group, respectively. Reactogenicity/safety endpoints were within the same range for all vaccines. In children aged 6-35 months, immune responses with Flu-50 fulfilled regulatory criteria but did not meet the predefined criteria for non-inferiority vs. control. This appeared to be due to differences in immunogenicity in children aged <18 months. © 2013 Landes Bioscience.
Colaborador(es) u otros Autores:	Weber M.A.R. Lau Y.-L. Nelson E.A.S. Kerdpanich A. Huang L.-M. Silas P. Qaqundah P. Blatter M. Jeanfreau R. Lei P. Jain V. El Idrissi M. Feng Y. Innis B. Peeters M. Devaster J.-M.
Fecha de publicación :	2013
Tipo de publicación:	Artículo
Formato:	pdf
Identificador del Recurso :	10.4161/hv.25363
Fuente:	Human Vaccines and Immunotherapeutics 9(9):1978 - 1988
URI :	http://repositorio.pediatria.gob.mx:8180/handle/20.500.12103/2465
Idioma:	eng
Aparece en las colecciones:	Artículos

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