NCT07282795

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

Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe, a High-dose Trivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 670 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Influenza Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Efluelda® Pre-filled syringe	Pharmaceutical Form: Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration

Timeline

• Start date: 2026-10-01
• Primary completion: 2029-02-22
• Completion: 2029-03-20
• First posted: 2025-12-15
• Last updated: 2026-03-31

Regulatory

• FDA-regulated drug study