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Efluelda® Pre-filled syringe
Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe
Ensayo de Sanofi en Influenza Immunization · Healthy Volunteers (del registro, en inglés).
- Fase
- no aplica
- Estado
- Aún sin reclutar
- Participantes
- 670
- Fin del objetivo primario
- feb 2029
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en oct 2026.
Qué mide
Occurrence of solicited injected site reactions. (Up to 7 days after vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroTo objective of this study is to investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda® in adults aged 65 years or older under routine clinical practice, as per approved indications This is an open-label, multi-center, observational active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Regulation on the Operation of Risk Management Plans". The study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT07282795), actualizada en mar 2026.