단계 미표기모집 예정

Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe

연구 개요

To 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.

스폰서
리드: 사노피
적응증
Influenza Immunization, Healthy Volunteers
중재
Efluelda® Pre-filled syringe
목표 등록
670
시작일
2026-10-01
완료(예정)
2029-03-20

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