A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Focetria

CompletadoClinicalTrials.gov

ID: NCT01040741Tipo: OBSERVATIONALInicio: 1 de dic de 2009Fin estimado: 1 de mar de 2011

Traducción no disponible, mostrando original

Resumen

This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.

Elegibilidad

Edad mínima: 6 MonthsSexo: ALL

Criterios de inclusión

Subject's age in accordance with the approved product label of the country where the study is conducted
Subjects will be vaccinated with Focetria®, independently of this study.
Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

Criterios de exclusión

• Received any prior H1N1 vaccination

Intervenciones

other

Non-intervention observational study

Ubicaciones

Hospital Garrahan

Combate de Los Pozos 1881, Buenos Aires F.D., Argentina

Hospital de Ninos "Dr. Ricardo Gutierrez"

Gallo 1330, Buenos Aires F.D., Argentina

Hospital Nuestra Señora de la Misericordia

Belgrano 1500, Córdoba Province, Argentina

Hospital Pediatrico del Niño Jesus

Castro Barros 650 - San Martín, Córdoba Province, Argentina

Sanatorio Mayo Privado S.A.

Humberto Primo 520, Córdoba Province, Argentina

Hospital Pediatrico "Dr. Humberto Notti"

Bandera de Los Andes 2603 Villa Nueva, Guaymallen Mendoza, Argentina

Patrocinadores

PrincipalNovartis Vaccines

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