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Quadrivalent Influenza Vaccine
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23
Ensayo de Sanofi en Influenza (Healthy Volunteers) (del registro, en inglés).
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 1.001
- Centros
- 15
- Fin del objetivo primario
- nov 2022
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en oct 2022.
Qué mide
Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda® (Within 7 days after vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) of suspected adverse drug reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2022/23. The secondary objectives of the study are: * To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®) * To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05568979), actualizada en mar 2024.