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Post Authorization Safety Study of the Pandemic A/H1N1 Influenza Vaccines in Children and Adults

Ensayo de Sanofi en Influenza · Swine-Origin A/H1N1 Influenza Virus (del registro, en inglés).

Más ensayos de: Gripe.

Fase

no aplica

Estado

Completado

Participantes

3.934

previstos

Centros

5

Fin del objetivo primario

ene 2011

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en dic 2009.

Qué mide

Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines. (21 days post-vaccination and entire study duration) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring. Primary objective: To describe the incidence of serious adverse events and adverse events of special interest (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups. Secondary objective: To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or PANENZA administration in different age groups up to 21 days after the last vaccination.This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01032980), actualizada en sep 2015.