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Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
Sponsor: Sanofi
Summary
To investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda Tetra in adults aged 65 years or older under routine clinical practice, as per approved indications. 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.
Official title: Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe, a High-dose Quadrivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea.
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
OBSERVATIONAL
Enrollment
670
Start Date
2026-10-01
Completion Date
2028-01-31
Last Updated
2025-12-15
Healthy Volunteers
Yes
Interventions
Efluelda Tetra Pre-filled syringe
Suspension for injection in a pre-filled syringe
Locations (1)
Investigational Site Number : 001
Seoul, Seoul-teukbyeolsi, South Korea