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

NCT06694025 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 670

Last updated 2025-12-15

No results posted yet for this 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.

Conditions

  • Immunization
  • Influenza (Healthy Volunteers)

Interventions

BIOLOGICAL

Efluelda Tetra Pre-filled syringe

Suspension for injection in a pre-filled syringe

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-12-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694025 on ClinicalTrials.gov