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

NCT07282795 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 670

Last updated 2026-03-31

No results posted yet for this study

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

BIOLOGICAL

Efluelda® Pre-filled syringe

Pharmaceutical Form: Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration

Sponsors & Collaborators

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-02-22
Completion
2029-03-20
FDA Drug
Yes

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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 NCT07282795 on ClinicalTrials.gov