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NOT YET RECRUITING
NCT06694025

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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

BIOLOGICAL

Efluelda Tetra Pre-filled syringe

Suspension for injection in a pre-filled syringe

Locations (1)

Investigational Site Number : 001

Seoul, Seoul-teukbyeolsi, South Korea