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Clinical Trials in South Korea / NCT06694025
Starting soon Observational

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

NCT06694025 · tracked via the Priya Life Science South Korea tracker
Sponsor
Sanofi
Phase
Observational
Started
2026-10-01
Last updated
2025-12-15

Condition(s) studied

ImmunizationInfluenza (Healthy Volunteers)

Investigational drug(s) / intervention(s)

Efluelda Tetra Pre-filled syringe

Efluelda Tetra Pre-filled syringe: Suspension for injection in a pre-filled syringe

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Adults aged 65 years or older on the day of enrollment * The informed consent form has been signed and dated * Receipt of 1 dose of Efluelda Tetra on the day of enrollment according to the approved local product label Exclusion Criteria: * Previous history of enrollment in this study * Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure

Primary outcome measure(s)

  • Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions — From baseline up to 7 days after vaccination
  • Occurrence of unsolicited AEs and ADRs — From baseline up to Visit 2 (28-35 days) after vaccination
  • Occurrence of unexpected AEs and ADRs — From baseline up to participant's last contact after vaccination (36-42 days)
  • Occurrence of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) — From baseline up to participant's last contact after vaccination (36-42 days)
  • Occurrence of AE of special interest (AESI) — From baseline up to participant's last contact after vaccination (36-42 days)

Trial sites (1)

FacilityCityRegionStatus
Investigational Site Number : 001 Seoul Seoul-teukbyeolsi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06694025 on ClinicalTrials.gov ↗ ← All trials in South Korea