A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age

CompletadoFase 3ClinicalTrials.gov

ID: NCT01346592Tipo: INTERVENTIONALInicio: 1 de abr de 2011Fin estimado: 1 de jul de 2012

Traducción no disponible, mostrando original

Resumen

This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to \< 72 Months of Age.

Elegibilidad

Edad mínima: 6 MonthsEdad máxima: 72 MonthsSexo: ALL

Criterios de inclusión

Children 6 months to 72 months of age.

Criterios de exclusión

Who had been hospitalized at the time of enrollment
Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein
Who had known impairment of the immune function
Who had fever interfering with normal daily activities at the time of enrollment
Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study
Concomitant participation in another clinical study
Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule.

Intervenciones

biological

Trivalent split influenza vaccine (TIV)

biological

MF59-adjuvanted trivalent influenza vaccine (aTIV)

biological

Licensed comparator trivalent split influenza vaccine (comparator TIV)

Ubicaciones

401 Paideia Jeronimo Salguero 2835 Piso 1

Buenos Aires, Argentina

402 Hospital de Ninos Gallo 130

Buenos Aires, Argentina

403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020

Córdoba, Argentina

405 Hospital Pediatrico Nino Jesus Castro Barros 650

Córdoba, Argentina

406 Hospital Nostra Senora de la Misericordia Belgrano 1500

Córdoba, Argentina

407 Centro Pediatrico Caballito Directorio 1658

Cuidad Automa de Beunos Aires, Argentina

408 Centro de Salud 31 Serpa y Republica del Libano

Mendoza, Argentina

409 Centro de Salud 16 Alpatacal y Chile

Villa Nueva, Argentina

Patrocinadores

PrincipalNovartis Vaccines

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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